Fdahelp.us Review

Based on looking at the website fdahelp.us, this review finds it to be a legitimate and ethically sound service for assisting businesses with FDA registration requirements. The site clearly outlines its services, provides verifiable contact information, and emphasizes compliance with FDA regulations, which is crucial for ethical business practices. Their transparent pricing and detailed explanation of FDA processes also contribute to a positive assessment.

Here’s an overall review summary:

• Legitimacy: Appears legitimate, part of Liberty Management Group Ltd.
• Ethical Standing: Strong, promotes compliance and avoids misleading claims.
• Transparency: High, with published fees and clear explanations.
• Service Scope: Comprehensive, covering food, drug, medical device, and cosmetic FDA registrations.
• Contact Information: Readily available and specific contact numbers for different departments.
• Customer Verification: Offers a certificate verification tool on their website.
• FDA Compliance Emphasis: Clearly states FDA does not issue certificates, and registration doesn’t imply approval.

Fdahelp.us, operating under Liberty Management Group Ltd, positions itself as a consulting firm dedicated to assisting domestic and foreign establishments in navigating the complex world of FDA regulations. They provide a range of services from initial FDA registration and US FDA Agent requirements to annual renewals and specific product listings for food, drugs, medical devices, and cosmetics. The website’s strength lies in its transparency regarding pricing and its clear differentiation between FDA registration and FDA approval, a common point of confusion for businesses. This emphasis on accurate information and adherence to regulatory standards aligns well with ethical business practices, promoting fair dealing and consumer safety. For any business needing assistance with FDA compliance, especially foreign entities requiring a US FDA Agent, fdahelp.us presents itself as a credible and reliable option. Their direct links to official FDA resources for verifying 510k clearances further solidifies their commitment to transparency and verifiable success.

Here are some of the best alternatives for businesses seeking regulatory compliance assistance, focusing on ethical and beneficial services:

• Registrar Corp

  • Key Features: Comprehensive FDA compliance assistance, including registration, US Agent services, and regulatory training. Offers assistance with various product types.
  • Average Price: Varies significantly based on specific services and company size. generally competitive.
  • Pros: Highly reputable, extensive experience, wide range of services, excellent customer support, well-established in the industry.
  • Cons: Pricing might be higher for more complex cases, can be overwhelming for very small businesses due to the breadth of services.

• U.S. Agent, Inc.

  • Key Features: Specializes in U.S. Agent services for foreign establishments, FDA registration assistance, and regulatory consulting.
  • Average Price: Typically offers tiered pricing for US Agent services and registration packages.
  • Pros: Focused expertise on US Agent requirements, cost-effective for foreign companies primarily needing this specific service, streamlined process.
  • Cons: More specialized, so might not offer as broad a range of general regulatory consulting as larger firms.

• Intertek

  • Key Features: A global leader in assurance, testing, inspection, and certification. Provides extensive regulatory advisory services, including FDA compliance, quality management, and product safety.
  • Average Price: High-end, tailored project-based pricing.
  • Pros: Global reach, highly accredited, comprehensive services beyond just FDA registration, strong technical expertise, known for meticulous quality.
  • Cons: Premium pricing, potentially less personalized for smaller operations compared to dedicated FDA consulting firms.

• NSF International

  • Key Features: Focuses on public health and safety. Offers consulting, auditing, and certification services for food, water, and health sciences industries, including FDA compliance.
  • Average Price: Project-specific, generally competitive for their specialized areas.
  • Pros: Strong reputation for public health, expertise in specific sectors like food and water, ethical focus on safety and quality.
  • Cons: May not cover as broad a range of FDA product types as other general regulatory consultants.

• Emergo by UL

  • Key Features: Specialized in medical device regulatory affairs. Provides consulting for FDA submissions, quality management systems, and international regulatory strategies.
  • Average Price: Custom quotes based on complexity of medical device projects.
  • Pros: Deep expertise in medical devices, global network, well-regarded for regulatory strategy in this niche.
  • Cons: Highly specialized. not suitable for food, drug, or cosmetic companies.

• Qserve Group

  • Key Features: Global medical device consulting and CRO services. Offers FDA regulatory strategy, QMS implementation, and clinical research support.
  • Average Price: Project-based, reflects specialized medical device consulting rates.
  • Pros: Strong focus on medical devices, international regulatory knowledge, supports entire product lifecycle from concept to market.
  • Cons: Exclusively for medical devices, not a general FDA compliance provider for other industries.

• Greenlight Guru Medical Device QMS Software

  • Key Features: While not a consulting service, it’s a QMS Quality Management System software platform designed specifically for medical devices to aid in FDA compliance. Helps manage design controls, risk, and document control.
  • Average Price: Subscription-based, varies by number of users and features.
  • Pros: Streamlines QMS, improves compliance efficiency, reduces manual errors, great for long-term internal management.
  • Cons: It’s a software solution, not a direct human consulting service. requires internal expertise to utilize effectively.

Find detailed reviews on Trustpilot, Reddit, and BBB.org, for software products you can also check Producthunt.

IMPORTANT: We have not personally tested this company’s services. This review is based solely on information provided by the company on their website. For independent, verified user experiences, please refer to trusted sources such as Trustpilot, Reddit, and BBB.org.

Fdahelp.us Review & First Look

When you first land on fdahelp.us, the immediate impression is one of professionalism and clarity.

The website presents itself as a dedicated resource for businesses navigating the intricate requirements of FDA registration for various products, including food, drugs, medical devices, and cosmetics. This is not a “fly-by-night” operation.

It’s a well-structured site aiming to provide a necessary service.

The homepage quickly establishes their core offerings: FDA registration, US FDA Agent services, and renewal assistance.

Initial Impressions: Professionalism and Clarity

The layout is clean, with clear navigation leading to specific service pages. You’re not left guessing what they do.

The language is straightforward, focusing on regulatory compliance rather than overly technical jargon, making it accessible to a wide audience.

This immediate transparency helps build trust, which is a key factor in choosing a regulatory consultant. It’s like walking into a well-organized office. you know exactly where to go and what to expect.

Verifiable Credentials and Affiliations

A quick scroll reveals that fdahelp.us is part of Liberty Management Group Ltd., an FDA, CE Marking, and ISO consulting firm. This affiliation is crucial. It indicates a broader expertise and a more established presence in the regulatory consulting world. The site also highlights their physical address in Aurora, Illinois, USA, alongside multiple contact phone numbers categorized by product type Food, Drug, Cosmetics, Medical Device. This level of detail in contact information is a strong indicator of legitimacy and commitment to client accessibility. They don’t shy away from being reachable.

Understanding the Service Scope

Fdahelp.us clearly defines who needs to register with the FDA, providing examples like food manufacturers, drug producers, and medical device importers.

They explicitly mention the mandatory requirement for foreign establishments to identify a US FDA Agent, a service they provide. Annonces-legale.com Review

This detailed explanation of service scope is invaluable for businesses trying to understand their obligations, demonstrating that the firm genuinely understands the nuances of FDA regulations.

It’s like having a seasoned guide for a complex journey.

Fdahelp.us Pros & Cons

Delving deeper into fdahelp.us reveals several strong points that make it a compelling choice for FDA compliance assistance, alongside a few areas that prospective clients should be aware of.

Like any service, it has its strengths and weaknesses, but for the most part, the pros heavily outweigh the cons, especially for businesses seeking reliable regulatory guidance.

Transparent Pricing Structure

One of the most significant advantages of fdahelp.us is their commitment to publishing all service fees on their website. In a field where consulting fees can often be opaque and based on hourly rates that escalate unpredictably, this transparency is a breath of fresh air. They state, “All our prices are published on the LMG website, which will help you calculate the total cost involved before starting the project.” This allows businesses to budget effectively and avoids any unpleasant surprises down the line. It’s a clear signal of integrity, ensuring clients know exactly what they’re signing up for before committing. This is a huge win for financial planning, making the decision process much simpler.

Clear Disclaimer on FDA Certification and Approval

The website does an excellent job of educating potential clients about the realities of FDA registration. They explicitly state: “FDA Registration or FDA registration number does not denote FDA certification or FDA approval of your facility or products. Any representation of the FDA registration number on the product label or labeling which implies FDA certification or FDA approval of a facility or product is misleading and may cause misbranding of the product.” This is a critical piece of information that many businesses, particularly those new to the US market, might misunderstand. By proactively clarifying this, fdahelp.us demonstrates its ethical approach and commitment to preventing misrepresentation, which is paramount in consumer protection and regulatory compliance. This honesty builds significant trust.

Extensive Portfolio of 510k Clearances

Fdahelp.us showcases a substantial list of 510k premarket notification numbers, with direct links to the FDA’s official database for verification. This “Experience Our Expertise: View Our 510k Portfolio” section is a powerful testament to their practical success in assisting medical device companies. Each link leads directly to the FDA’s Accessdata website e.g., K243001, allowing potential clients to independently verify their track record. This level of verifiable success is rare and highly reassuring, providing concrete proof of their capabilities and expertise in navigating complex regulatory pathways. It’s like seeing a contractor’s successful past projects firsthand, showing they deliver.

Dedicated Contact Channels

The website provides specific phone numbers for different product categories Food, Drug, Cosmetics, Medical Device in addition to a general inquiry number and email.

This specialized contact approach ensures that clients can reach consultants who are experts in their specific product area, leading to more efficient and accurate guidance.

This granular approach to communication is a significant advantage, saving clients time and ensuring they speak to the right person from the start. Vintageducation.com Review

Focus on Regulatory Compliance, Not Approval

While not explicitly a “con,” it’s important for clients to understand that fdahelp.us is a consulting firm. Their role is to assist with registration and compliance with FDA regulations. They do not “get” FDA approval for products, as FDA approval is a rigorous process specific to certain high-risk medical devices and new drugs, requiring extensive data and clinical trials. Their service is about ensuring the necessary paperwork is correctly filed and processes are followed. This distinction is crucial for managing client expectations, though the website does make this clear in its disclaimers. It’s not a magic bullet for approval, but a critical guide for navigating the requirements.

Fdahelp.us Alternatives

While fdahelp.us offers a solid service, the world of FDA regulatory compliance is vast, with many reputable firms offering similar or specialized assistance.

Exploring alternatives is always a wise step to ensure you find the best fit for your specific needs, budget, and industry.

These alternatives often bring their unique strengths, from global reach to niche expertise, and all operate ethically within the framework of regulatory assistance.

Registrar Corp: The Veteran Player

Registrar Corp is arguably one of the most well-known and comprehensive FDA compliance firms globally.

They offer a wide array of services, including FDA registration, U.S.

Agent services, food facility registration, medical device listing, and regulatory training.

• Key Differentiator: Their long-standing presence and vast experience across almost all FDA-regulated industries make them a go-to for many international and domestic companies. They often provide extensive educational resources and webinars.
• Ideal for: Companies seeking a highly established, full-service firm with broad expertise and a strong global footprint.

U.S. Agent, Inc.: Niche Specialization

U.S.

Agent, Inc.https://www.usagentinc.com/ focuses specifically on providing US Agent services for foreign establishments, alongside core FDA registration assistance.

This specialization allows them to offer highly competitive pricing and streamlined processes for this critical requirement. Halupvc.com Review

• Key Differentiator: Their targeted approach means they are exceptionally efficient for foreign companies primarily needing a reliable US Agent and fundamental registration support.
• Ideal for: Foreign companies whose primary need is a compliant and cost-effective US Agent, with straightforward FDA registration requirements.

Intertek: Global Testing and Certification Giant

Intertek is a global leader in assurance, testing, inspection, and certification services.

Their regulatory advisory services, including FDA compliance, are part of a much larger portfolio that also covers product safety, quality management systems, and chemical regulations.

• Key Differentiator: As a large, multinational company, Intertek can leverage extensive laboratory and testing capabilities alongside their regulatory consulting, offering an integrated solution for product development and market entry.
• Ideal for: Larger corporations or companies seeking integrated solutions that combine regulatory compliance with product testing, certification, and broader quality assurance services.

NSF International: Public Health and Safety Ethos

NSF International is a non-profit organization dedicated to public health and safety.

They provide consulting, auditing, and certification services, particularly strong in the food, water, and health sciences sectors.

Their FDA compliance assistance is rooted in their mission to protect public health.

• Key Differentiator: Their non-profit status and strong focus on public health and safety imbue their services with an inherent ethical emphasis. They are known for their rigorous standards and independent evaluations.
• Ideal for: Companies in the food, dietary supplement, water, or health sciences industries looking for a partner with a strong public health mission and recognized certification programs.

Emergo by UL: Medical Device Regulatory Specialists

Emergo by UL stands out for its deep specialization in medical device regulatory affairs.

They assist companies with FDA submissions including 510k, PMA, quality management system implementation, and global regulatory strategies specifically for medical devices.

• Key Differentiator: Unparalleled expertise in the complex and highly regulated medical device sector, backed by UL’s global safety science reputation.
• Ideal for: Medical device manufacturers and importers needing highly specialized, in-depth regulatory guidance for product development, market access, and post-market compliance.

Qserve Group: European and Global Medical Device Experts

Qserve Group is a global medical device consulting and CRO Contract Research Organization that offers comprehensive support, from regulatory strategy to clinical research.

While based in Europe, they have strong expertise in FDA regulations for medical devices.

• Key Differentiator: Their integrated approach combining regulatory consulting with clinical research services provides a holistic solution for medical device companies navigating global markets.
• Ideal for: Medical device companies, especially those with European roots or global aspirations, seeking comprehensive regulatory and clinical support for their products.

Greenlight Guru: QMS Software for Medical Devices

Greenlight Guru isn’t a consulting firm, but a leading Quality Management System QMS software platform specifically designed for medical device companies. Thesocialmarketeers.org Review

It helps manage design controls, risk management, document control, and other QMS processes essential for FDA compliance.

• Key Differentiator: This software provides a digital, automated backbone for QMS, making it easier to maintain compliance, prepare for audits, and manage regulatory documentation.
• Ideal for: Medical device companies looking to modernize and streamline their internal quality management processes to ensure ongoing FDA and ISO compliance, complementing their regulatory consulting efforts.

How to Cancel fdahelp.us Subscription

Understanding how to manage or cancel services is crucial for any business relationship.

While fdahelp.us emphasizes its competitive fees and transparent pricing, situations may arise where a client needs to cancel a subscription or specific service.

Given that fdahelp.us operates within a professional consulting framework, cancellation policies would typically align with standard business practices.

General Cancellation Principles for Consulting Services

For consulting services like those offered by fdahelp.us, cancellation procedures are generally outlined in the service agreement or terms and conditions signed by the client. These agreements typically cover:

• Notice Period: A required period of notice e.g., 30 or 60 days before cancellation can take effect.
• Refund Policy: Details on whether partial refunds are available for pre-paid services or if only future billing is stopped.
• Work in Progress: How ongoing work is handled, including fees for services already rendered.
• Data Handover: Procedures for handing over any relevant documents or data related to the client’s FDA registrations.

Steps to Initiate a Cancellation with fdahelp.us

Based on common practices for professional service firms and the information available on their website regarding contact methods, the most direct approach to cancel a service or subscription with fdahelp.us Liberty Management Group Ltd. would involve:

1. Review Your Agreement: First, locate and carefully read the service agreement or contract you signed with fdahelp.us or Liberty Management Group Ltd.. This document will contain the specific terms and conditions regarding service termination, notice periods, and any associated fees.
2. Contact Customer Service: Reach out directly to fdahelp.us using the contact information provided on their website.
   • Email: Send an email to [email protected] clearly stating your intent to cancel, your company name, and any relevant service agreement or client ID numbers.
   • Phone Call: Call the appropriate phone number for your service area e.g., +1 630 270-2921 for general inquiries, or the specific numbers for Food, Drug, Medical Device, or Cosmetics. Be prepared to discuss your account and reasons for cancellation.
3. Formal Written Notice: Even if you call, it’s advisable to follow up with a formal written notice via email. This creates a documented record of your cancellation request and the date it was sent. Include all pertinent details in the email, such as:
   • Your company’s legal name.
   • Your contact information.
   • The specific services you wish to cancel.
   • The effective date of cancellation, keeping any notice periods in mind.
   • A request for confirmation of cancellation from fdahelp.us.
4. Confirm and Verify: After submitting your cancellation request, ensure you receive a confirmation from fdahelp.us. Keep this confirmation for your records. Verify that any recurring payments cease as expected.

Important Considerations

• Annual Renewals: Be particularly mindful of annual renewal cycles, especially for US FDA Agent services or FDA registration renewals. Many services are tied to these cycles, and missing a cancellation deadline might result in being billed for another year.
• Documentation: Always maintain clear records of all communications related to your cancellation, including dates, names of representatives spoken to, and copies of emails.
• Impact on Compliance: Understand the implications of canceling a service, especially the US FDA Agent service, for your ongoing FDA compliance. Foreign establishments must maintain a US Agent. If you cancel their service, you will need to appoint a new US Agent promptly to avoid non-compliance issues with the FDA.

By following these steps and understanding the general principles of service cancellation for professional consulting firms, clients can manage their relationship with fdahelp.us effectively.

Fdahelp.us Pricing

One of the standout features of fdahelp.us, which aligns with best practices for ethical and transparent business operations, is their commitment to publishing their pricing structure directly on their website. This is a significant advantage in the consulting world, where pricing can often be shrouded in ambiguity or require direct quotes after lengthy consultations. They explicitly state, “All our prices are published on the LMG website, which will help you calculate the total cost involved before starting the project.” This approach fosters trust and enables businesses to plan their budgets effectively.

Transparency in Fees

The fact that they publish their fees on the main LMG website likely linked from fdahelp.us is crucial.

This proactive transparency helps clients understand the financial commitment upfront, avoiding the common frustration of hidden costs or escalating hourly rates. Licensestudyguide.com Review

This model is particularly beneficial for small to medium-sized businesses that need clear financial projections and cannot afford unexpected expenditures.

It’s like buying a product with a clear price tag, rather than having to haggle or wait for a custom quote.

Services with Published Fees

Based on the homepage text, fdahelp.us under Liberty Management Group Ltd. offers competitive fees for a range of services, including:

• FDA registration: For various product types food, drug, medical device, cosmetic.
• US FDA Agent service: A mandatory requirement for foreign establishments.
• NDC number request: For drug products.
• Drug listing: For pharmaceutical products.
• Label review: To ensure compliance with FDA labeling regulations.
• Other services: Which implies additional regulatory assistance.

This comprehensive list suggests that clients can get a clear picture of the costs associated with the core FDA compliance needs.

How to Find Specific Pricing Details

While the fdahelp.us homepage states that prices are published on the LMG website, users would typically navigate to a dedicated “Fees,” “Pricing,” or “Services” section on either fdahelp.us or the parent Liberty Management Group Ltd. site.

This section would likely detail the fixed fees for each service, potentially offering package deals for combined services e.g., registration plus US Agent.

For example, a user looking for FDA food facility registration fees would expect to find a clear, upfront cost rather than a “contact us for a quote” prompt.

This transparency empowers businesses to make informed decisions without time-consuming inquiries.

Example of Pricing Scenarios Illustrative

While specific numbers aren’t provided in the given text, a typical pricing structure for such services might look like this:

• FDA Food Facility Registration: Fixed fee e.g., $500 – $1,000
• US FDA Agent Service Annual: Fixed annual fee e.g., $1,000 – $2,000
• Medical Device Initial Registration: Fixed fee e.g., $750 – $1,500
• Drug Listing: Fixed fee per drug e.g., $300 – $600
• Label Review: Per product/label e.g., $200 – $500

These figures are illustrative and depend on market rates, the complexity of the service, and the specific offering. The key takeaway from fdahelp.us is that these numbers are available to the client upfront, which is a significant ethical and practical advantage. This practice demonstrates confidence in their value and respect for the client’s financial planning. Dirtbusterscleaning.org.uk Review

FDAhelp.us vs. Competitors

While many firms offer similar services, their approaches, pricing models, and specialized expertise can vary significantly.

Comparing fdahelp.us with competitors like Registrar Corp or U.S.

Agent, Inc., highlights its strengths and helps potential clients understand where it fits in the market.

FDAhelp.us’s Unique Positioning

Fdahelp.us, operating under Liberty Management Group Ltd., positions itself as a balanced provider, offering comprehensive FDA registration and US Agent services with a strong emphasis on published, competitive pricing. This transparency is a key differentiator. They aim to provide quality service at a reasonable price within a minimum timeframe, emphasizing accurate cost estimates over uncertain hourly fees. Their explicit public portfolio of 510k clearances also sets them apart by providing verifiable success stories directly linked to FDA data.

Versus Full-Service Giants e.g., Registrar Corp, Intertek

• Fdahelp.us: Offers a focused suite of core FDA registration and US Agent services. Its strength lies in clear pricing and a direct approach, often appealing to businesses looking for straightforward assistance without complex, long-term consulting engagements. Their 510k portfolio indicates a strong capability in medical devices.
• Registrar Corp: A larger, more established global firm that offers a much broader range of services, including extensive training, audit preparation, and specialized compliance programs beyond basic registration. They have a vast network and a reputation for handling complex, multi-faceted regulatory challenges.
• Intertek: A massive global testing, inspection, and certification company. Their regulatory advisory services are part of a much larger ecosystem. They can offer integrated solutions from product design to market access, including laboratory testing.
• Comparison: Fdahelp.us might be more agile and cost-effective for direct registration needs. The larger firms offer more extensive hand-holding and specialized services, which come at a higher price point, potentially through less transparent quoting processes. For simple registration, fdahelp.us might offer better value and speed. For complex product development requiring lab work, Intertek could be a one-stop shop, while Registrar Corp excels at broad-spectrum, deep-dive regulatory support.

Versus Niche Specialists e.g., U.S. Agent, Inc., Emergo by UL

• Fdahelp.us: While they cover food, drug, and cosmetics, their prominent display of 510k portfolio suggests a strong, perhaps growing, focus on medical devices. They offer broad regulatory assistance but also specific expertise in certain areas.
• U.S. Agent, Inc.: Highly specialized in providing US Agent services, making them extremely efficient and potentially more budget-friendly for foreign companies whose primary need is meeting the US Agent requirement. Their focus is narrower.
• Emergo by UL / Qserve Group: These firms are almost exclusively focused on medical devices, providing deep, specialized expertise in areas like clinical trials, quality management systems QMS, and intricate premarket submissions PMA, 510k. Their consultants are highly experienced in this single, complex sector.
• Comparison: If your sole need is a US Agent and basic registration, U.S. Agent, Inc. might be the most streamlined choice. If you’re a medical device company with intricate requirements, Emergo by UL or Qserve Group offer unparalleled, albeit premium, specialized guidance. Fdahelp.us sits in the middle, offering strong medical device capabilities as evidenced by their 510k portfolio alongside general FDA registration for other product types. They represent a good balance of comprehensive service and focused expertise without being hyper-specialized.

Pricing Model Comparison

• Fdahelp.us: Explicitly prides itself on publishing fees and providing accurate upfront estimates. This is a significant competitive advantage for budgeting.
• Competitors: Many consulting firms, especially the larger ones, operate on a quote-based system or hourly rates, which can lead to cost uncertainties for clients. While they provide quotes, the initial transparency isn’t always as immediate as fdahelp.us.

In summary, fdahelp.us presents itself as a highly transparent and competent FDA regulatory consulting firm with a strong emphasis on clear pricing and verifiable results, particularly in the medical device sector. It serves as an excellent option for businesses seeking reliable and straightforward FDA registration and compliance assistance, balancing broad service offerings with focused expertise, and standing out through its ethical commitment to upfront cost transparency.

Frequently Asked Questions

What is fdahelp.us?

Fdahelp.us is a website that provides FDA regulatory consulting services, assisting domestic and foreign establishments with FDA registration, US FDA Agent requirements, annual renewals, and other compliance needs for products like food, drugs, medical devices, and cosmetics. It operates under Liberty Management Group Ltd.

Is fdahelp.us a legitimate company?

Yes, based on the information provided on their website, fdahelp.us appears to be a legitimate company.

It is part of Liberty Management Group Ltd., provides verifiable contact information including a physical address in Illinois, USA, and showcases a portfolio of successful FDA 510k clearances.

What services does fdahelp.us offer?

Fdahelp.us offers a range of services including FDA registration for food, drug, medical device, and cosmetic facilities, US FDA Agent services for foreign establishments, annual registration renewals, NDC number requests, drug listing, label review, and assistance with various FDA registration forms.

Does fdahelp.us provide FDA certification or approval?

No, fdahelp.us explicitly states that FDA registration or a registration number does not denote FDA certification or approval of a facility or products. Wizerd.com Review

They clarify that any representation implying FDA certification or approval based on registration is misleading.

Their service is to assist with registration and compliance.

How transparent is fdahelp.us about its pricing?

Fdahelp.us is highly transparent about its pricing.

They state that all their service fees are published on the Liberty Management Group Ltd.

Website, allowing clients to calculate the total cost involved before starting any project, which is a significant advantage in the consulting industry.

Can foreign companies use fdahelp.us for US FDA Agent services?

Yes, fdahelp.us specifically highlights that they provide US FDA Agent services, which is a mandatory requirement for all foreign establishments during the FDA registration process.

What is a US FDA Agent?

A US FDA Agent is a person or entity residing in the United States who acts as a communication liaison between the FDA and a foreign establishment.

This is a mandatory requirement for foreign companies that manufacture, process, pack, or store regulated products in the USA.

Does fdahelp.us help with FDA registration renewals?

Yes, fdahelp.us assists with FDA registration renewals for drug, API, and medical device establishments annually, and for food facilities every even-numbered year, ensuring compliance and preventing product detention due to non-renewal.

How can I verify the services provided by fdahelp.us?

Fdahelp.us provides a “Verify Certificate” feature on their website for clients and their customers to verify certificates of FDA registration issued by Liberty Management Group Ltd. Brandbusters.net Review

Additionally, they list numerous 510k portfolio numbers with direct links to the official FDA database for independent verification of their successful medical device clearances.

What types of products does fdahelp.us help register?

Fdahelp.us helps with the FDA registration of food, drug, API Active Pharmaceutical Ingredient, medical devices, and cosmetic products.

Is there a phone number to contact fdahelp.us?

Yes, fdahelp.us provides multiple phone numbers, including a general contact number +1630 270-2921, and specialized lines for Food, Drug, Cosmetics, and Medical Device inquiries.

What is the advantage of using fdahelp.us over registering directly with the FDA?

While companies can register directly with the FDA, fdahelp.us offers expertise and guidance through the complex regulatory process, ensuring accuracy, minimizing errors, and providing a mandatory US FDA Agent for foreign entities, saving businesses time and potential compliance issues.

Does fdahelp.us offer label review services?

Yes, the website mentions that Liberty Management Group LTD offers label review services to ensure product labels comply with FDA regulations.

How long does FDA registration take with fdahelp.us?

While specific timelines are not provided, fdahelp.us states their mission is to provide quality service at a reasonable price within a minimum timeframe, suggesting an efficient process.

The actual duration can vary based on the specific type of registration and responsiveness of the client.

Does fdahelp.us provide assistance for ISO certification?

While fdahelp.us primarily focuses on FDA compliance, its parent company, Liberty Management Group Ltd., is also an ISO consulting firm, suggesting they can likely assist with or provide referrals for ISO certification.

What are the annual renewal periods for FDA registration?

Drug, API, and Medical Device establishments must renew annually between October 1st and December 31st.

Food facilities must renew between October 1st and December 31st of every even-numbered year once every 2 years. Saltandlaceintimates.com Review

What happens if I don’t renew my FDA registration?

If companies do not comply with FDA renewal requirements, the FDA may consider their products misbranded, which could lead to detention of the products.

Does fdahelp.us help with cosmetic facility registration?

Yes, fdahelp.us offers assistance with Cosmetic Facility Registration and Cosmetic Product Listing, adhering to the latest FDA regulations.

Can I get a free consultation from fdahelp.us?

The website doesn’t explicitly mention free consultations, but given their transparent pricing model, it’s common for such firms to offer initial discussions to understand client needs before formal engagement. It’s best to inquire directly.

What kind of “certificates” does fdahelp.us issue to clients?

Fdahelp.us issues a “certificate of FDA registration” to its clients for their records, free of cost.

This certificate is a third-party document verifying their assistance with the FDA registration process, not an official FDA-issued certificate.