Food and Drug Administration (FDA) regulations cover food contact materials, medical devices, food, cosmetics, and more. Understanding and implementing compliance with the relevant standards, documentation, labeling, and lab testing requirements often requires help from qualified experts.
In this guide, we list some of the leading companies offering FDA product compliance-related services for a wide range of products and materials. Each company profile includes an introduction, services, and qualifications.
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What kind of services do FDA consultants offer?
The FDA regulates a wide range of products including food contact materials, foods, biological products, medical devices, and others. Most FDA consultants focus on selected categories of products only, for example, medical devices or food and beverage. Thus, it’s important that you select one that focuses on the products you want to import or manufacture.
Many of these companies provide a full-circle solution on FDA compliance in order to get your product in the market, including:
- FDA regulatory submission
- FDA registration
- Compliance assistance
- Quality assurance
- Management controls
Recommended articles
You can learn more about FDA regulations in the following guides:
- FDA Product Lab Testing: A Complete Guide
- FDA Regulations For Medical Devices: An Overview
- List of Products Covered by FDA Regulations: An Overview
FDA Group
FDA Group is an organization that provides FDA-related services such as regulatory submissions, qualification reviews, and clinical operations. They claim that they have over 1,600 resources worldwide, also over 100 of whom are former FDA.
FDA Group offers consulting services for interpreting and acting on FDA regulations. They can connect you to former FDA officials as knowledgeable expert witnesses. You can also find case studies on their website, including some success stories concerning devices compliance, and regulatory consulting.
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Address: 290 Turnpike Road, Suite 200 Westborough, MA 01581, United States
TSG Consulting
TSG is a regulatory consultant that has offices in the US, Canada, France, Spain, Germany, and the UK. They provide regulatory and scientific support for food contact materials, agrochemicals, biocides, and antimicrobials industries.
They offer specific services for food contact products, including Generally Recognized As Safe (GRAS) notices, ingredients review, product registration, Food Contact Notification (FCN), and food additive petitions.
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Address: 1150 18th Street NW Suite 1000 Washington, DC 20036 United States
EMMA International
EMMA International is a global consulting firm for the medical device, pharmaceutical, biotechnology, combination products, and diagnostics industries. They focus on quality, regulatory, compliance services such as regulatory submission and post-market compliance.
According to their website, EMMA International is an ISO 9001 certified company. You can find more credentials on their websites such as WBENC and DOBE certifications. Also, they publish articles, webinars, case studies, and white papers on FDA-related topics.
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Address: 30150 Telegraph Rd, Suite 120, Bingham Farms, MI 48025, United States
Pharma-Bio Serv
Pharma-Bio Serv was founded in 1993 and provides consulting and quality professional services in the medical devices, pharmaceutical, and consumer product industries. Their services cover regulatory compliance, quality risk management, technology transfer, and other areas.
Pharma-Bio Serv helps companies to register with FDA and prepare their 510(k) pre-market submission. It also helps companies prepare or revise SOP, conduct QS compliance audits, conduct gap analysis, and other document preparation and risk control work a company needs to achieve FDA compliance.
Further, Pharma-Bio Serv is a publicly-traded company since 2006.
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Address: 6 Road 696, Dorado, Puerto Rico, United States
EAS Consulting Group
EAS Consulting Group is a consulting firm that provides regulatory solutions for industries including foods, pharmaceuticals, dietary supplements, and more. They have over 150 independent advisors and consultants providing consulting, training, and auditing services to ensure regulatory compliance.
EAS is also engaged with some major organizations such as AHPA, AOAC, FDAAA, and TMA. They claim that they are qualified to provide regulatory support for law firms such as expert witness services.
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Address: 1700 Diagonal Road, Suite 750, Alexandria, VA 22314, United States
Lachman Consultants
Lachman is a consulting company that provides technical and regulatory consulting services for pharmaceutical, biotechnology, biologics, diagnostic, device, and allied health industries. For example, they offer compliance consulting, regulatory submissions, training, and technical assistance.
In addition, they offer services such as on-site interim operational and management support, hands-on support for virtual companies, and remediate consent decrees.
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Address: 1600 Stewart Ave, Suite 604, Westbury, NY 11590, United States
Emergo by UL
Emergo by UL is an ISO 13485 certified consultant specializing in medical devices and in vitro diagnostic (IVD) compliance. They have over 30 offices worldwide including Hong Kong, Germany, France, Australia, the US, and more.
They offer FDA regulatory support for all sizes of medical device companies, for example, FDA submissions, project management, FDA premarket notification, and more. In addition, you can find webinars, device regulation guides, white papers, videos, and market data on their website, to learn more about their services.
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Address: 2500 Bee Cave Road, Building 1, Suite 300, Austin, TX 78746, United States
Ken Block Consulting
Ken Block Consulting is a US-based consulting firm that also has offices in the EU and Japan. They provide regulatory services to all sizes of medical device companies worldwide. They have direct experience interacting with FDA personnel during inspections, submission reviews, and meetings.
They offer FDA regulatory compliance services such as FDA registrations, device classifications, product listings, international import/export issues, on-site FDA investigations, and more. Also, they can also help you to assess the information you need to add to your product labeling.
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Address: 800 E Campbell Rd, Suite 202, Richardson, TX 75081, United States
The Weinberg Group
The Weinberg Group is a regulatory and compliance consultant located in Washington, DC in the United States. They provide biotech, medical devices, and pharmaceutical consulting services to all sizes of businesses.
They offer guidance and regulatory submission support, for instance in the field of orphan drug designation. Also, they can help with medical device submissions such as 510(k) premarket notification, premarket approval, and more.
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Address: 1129 20th ST NW, Suite 600, Washington, DC 20036, United States
Provision Consulting Group
Provision Consulting Group is a consulting company that provides services for FDA registration and compliance requirements. They focus on FDA-regulated industries including medical devices, food and beverages, dietary supplements, drugs, and cosmetic products.
They offer services such as FDA registration, product listings, submissions, US agent services, and more. Also, they can provide assistance with the quality system, for example, training, personnel qualification, document management, recalls, audit program, and more.
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Address: 100 N Barranca St #700, West Covina, CA 91791, United States
How about ISO audits for FDA biotech manufacturers and processors looking to achieve product approvals?
We have develop the only patented Urine Antibody Covid 19 Test and we distrubute also the best N°1 antigen test in the world tested over 122 tests we would like to have both tests register has home use to the FDA to sell into the USA can you please contact us
What about Biologics Consulting based in Alexandria, VA?
We are manufacturer of toothpaste in Africa and we want to export to united state and Canada.
Hello Edward,
I suggest you contact the listed companies directly. They will not respond here.