• List of FDA Consulting Companies: Our 9 Top Picks

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    FDA consultant companies

    FDA (Food and Drug Administration) 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.

    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 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.

    Product Areas
    • Medical devices
    • Biotech products
    • Manufacturing and engineering
    • Expert witness
    • Commissioning, qualification, and validation
    • Clinical operations

    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.

    Product Areas
    • Food contact materials
    • Agrochemicals
    • Biocides and antimicrobials
    • Ingredients review
    • Food Contact Notification (FCN)
    • Prepare Generally Recognized As Safe (GRAS) notice
    • FCM registration
    • Food additive petitions

    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.

    Product Areas
    • Medical devices
    • Pharmaceuticals
    • Digital health
    • IVDs
    • Gene and cell therapies
    • Combination products
    • Full circle consulting
    • Product development
    • Regulatory submission
    • Post-market compliance
    • Manufacturing and distribution
    • Quality system development and implementation

    Address: 30150 Telegraph Rd, Suite 120, Bingham Farms, MI 48025, 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.

    Product Areas
    • Foods
    • Pharmaceutical
    • Dietary supplements
    • Medical devices
    • Tobacco
    • Cannabis
    • Cosmetics
    • Regulatory strategies
    • Recall assistance
    • FDA enforcement actions
    • Insurance assessments
    • Facility and laboratory audits
    • Mock FDA inspections
    • US agent services
    • Product labeling

    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.

    Product Areas
    • Diagnostic devices
    • Medical devices
    • Pharmaceuticals
    • Biotechnology
    • Dietary supplement
    • Regulatory affairs
    • Audits and reviews
    • Compliance solutions
    • Document preparation
    • Inspection services
    • Quality assurance
    • Training services

    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.

    Product Areas
    • Medical devices
    • FDA 510(k) submissions
    • FDA IDM submissions
    • US agent representative
    • Premarket notification
    • QSR audits
    • FDA form 383 warning letter analysis
    • General regulatory assistance
    • Quality system assistance and training

    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.

    Product Areas
    • Medical devices
    • FDA regulatory compliance
    • FDA registration
    • Device classifications and product listings
    • On-site FDA visits and investigations
    • Submission reviews
    • QMS audits and mock FDA inspections
    • On-site training

    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.

    Product Areas
    • Biotech
    • Medical devices
    • Pharmaceutical
    • Regulatory strategy
    • FDA meetings
    • FDA submissions
    • Nonclinical drug development
    • Regulatory due diligence

    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.

    Product Areas
    • Medical devices
    • Drugs
    • Dietary supplements
    • Cosmetics
    • Food and beverages
    • FDA compliance
    • Investigational New Drug
    • New Drug application
    • Quality system
    • Cosmetic ingredient review

    Address: 100 N Barranca St #700, West Covina, CA 91791, United States

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    Disclaimer: The content on this website is provided for general information only. The content includes summaries written by our team members based on publicly available information about product safety standards, labeling, documentation, testing, processes, and other product compliance related topics. However, we don’t guarantee that we cover every single relevant regulation/standard/requirement, or that the information is free from errors, or covering every single scenario and exemption. We do make mistakes from time to time. We never provide legal advice of any sort.

    Changes/Updates: Product standards and substance restrictions are subject to frequent updates and changes. In addition, new regulations, standards, and/or requirements may also become effective at any time. We don’t update our articles whenever new standards/regulations/rules are added or changed. We recommend that you consult a lab testing company or other professional to get the latest information about mandatory standards/regulations in your market, country, or state. Lab testing companies generally stay up to date on new and updated standards and regulations.

    National/State-Level Standards/Regulations: Many articles don't cover all European national and US state standards, regulations, and requirements. We recommend that you consult a testing company or other professional to confirm all relevant (and current) national/state level standards and regulations.
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