The Food and Drug Administration (FDA) regulates a variety of products, including food contact materials like silverware and dishes, as well as medical devices. They also oversee cosmetics and drugs in order to ensure compliance with federal regulations.
The FDA maintains strict guidelines for what can be marketed and sold to consumers, so if you’re looking at selling anything that they regulate, it’s important to understand and follow all requirements and guidelines. With such an undertaking it can often be useful for companies to employ FDA consultants—professionals who are highly knowledgeable about all things related to FDA and other regulations that can help you navigate the approval process.
This guide offers a list of the best companies for FDA product compliance-related services to aid you as you search for the company that is right for you.
FDA Group
FDA Group is a company that provides FDA-related services such as regulatory submissions, qualification reviews, and clinical operations. They have staff with years of experience and expertise in interpreting, acting upon, or following up regulatory orders. FDA Group also offers consulting and legal advice for clients.
TSG Consulting
The regulatory consultants at TSG provide a wide range of expert services to the food, agrochemical, and pharmaceutical industries, including, for example, the safe use of chemicals used throughout our everyday lives. Their team includes offices in countries such as the US, Canada, France, and Spain, the latter of which houses one office dedicated solely to servicing that region’s needs from Latin American countries like Mexico that require care when importing goods into local markets due to very strict safety standards.
EMMA International
EMMA International is a global consulting firm for the medical device, pharmaceutical, and biotechnology industries. It focuses on quality regulatory services, such as submitting regulatory documents that are required by law or company policy without unnecessary delays. EMMA’s regulatory team ensures that products meet all applicable requirements set forth in FDA or other guidelines so clients can enjoy easy market access without risk of fines or penalties.
EAS Consulting Group
EAS Consulting Group is a consulting firm that specializes in providing regulatory solutions for industries including foods, pharmaceuticals, and dietary supplements. It has over 150 independent advisors to help ensure clients comply with all government regulations—from starting up an operation to maintaining it once established. EAS Consulting Group also provides auditing services to companies.
Lachman Consultants
Lachman is a consulting company that works with pharmaceutical, biotechnology, and other industries. It offers compliance services like inspections and regulatory submissions to help ensure all regulations are met in order for its clients’ products to be approved by the FDA. Lachman offers training courses on how to complete these processes effectively while also providing technical assistance when needed, such as helping submit applications at a low cost.
Emergo by UL
Emergo is a medical device and IVD compliance consulting company with offices all over the world. It has ISO 13485 certified specialists who can help clients meet tough international standards without needing to worry about getting into trouble when selling goods in new countries or regions of Asia Pacific, in particular. Emergo’s services range from helping small businesses get off on the right foot by meeting local requirements for product registration, through expert advice around risk management strategies, such as monitoring salesperson behavior during trips overseas.
The company offers a wide range of services to help navigate through the regulatory process. From project management and pre-market notification, to submissions for approval from the FDA—it has it all. Clients can also find webinars and white papers about key topics.
Ken Block Consulting
Ken Block Consulting is a US-based consulting firm that has offices in the EU and Japan. It provides regulatory services to all sizes of medical device companies worldwide. Services include: FDA interactions, such as submitting patents or marketing applications; meeting with agency officials during inspections; and meetings between company representatives and reviewed staff members. Further, it offers FDA regulatory compliance services, such as device classifications, product listings, and more. The company also assesses the information clients need for product labeling to make sure it is up to standard with all regulations in place.
The Weinberg Group
The Weinberg Group is a regulatory and compliance consultant located in Washington, DC that provides services for biotech companies. It supports all sizes of businesses with medical devices and pharmaceuticals. The company offers guidance and regulatory submissions support. It can help with medical device submissions, such as 510(k) pre-market notification and more complicated applications as well.
Provision Consulting Group
Provision Consulting Group is a leading company in the medical device, food, and beverage industries. It has been helping clients meet all federal safety regulations since 1991 with efficient services that are tailored specifically for each industry’s unique needs—from FDA registration requirements to recall notifications.
As a seasoned company, Provision Consulting Group has qualified staff members who can assist with quality system training for employees or even complete program audits to ensure that best practices are followed across all areas.
MDI Consultants
The MDI consulting team is a “premier” group with significant experience as former quality management department leaders. Since 1978, the consultants have fielded over 1 thousand clients in the medical device and pharmaceutical industries to offer solutions for their needs, including some of the most well-established names around.