FDA Compliance Consulting

 

 

We help companies in the food, drug, medical device, and cosmetics industries maintain FDA compliance.

 

Compliance Team Leader – Timothy E. Allen |Former Special Agent (U.S. Secret Intelligence Service and DOJ-OIG)

Of all the areas of federal compliance, U.S. Food and Drug Administration (FDA) compliance is perhaps the most unique . Although general rules, regulations and prohibitions apply generally, specific and highly technical rules also apply to companies in the food, drug, medical device and cosmetic industries. Different rules apply to different companies, so FDA compliance cannot be applied as a one-size-fits-all solution. On the contrary, companies must implement customized compliance programs and continually reassess their compliance obligations and efforts.

Is your company supervised by the FDA? If so, you need to prioritize compliance. The FDA has cracked down on violations in recent years. Companies that violate the Food, Drug, and Cosmetic Act (FDCA) and FDA regulations can face significant administrative and civil penalties, and FDA will not hesitate to take cases to U.S. courts if warranted. Department (DOJ). For law enforcement agencies.

Understanding Your Company's FDA Compliance Obligations

FDA compliance consultant means different things to different companies. Understanding this fact is an important first step in understanding your company's compliance obligations. From clinical trials to marketing, scientific claims to recalls, various aspects of a company's operations can impact FDA oversight depending on the type of product it sells.

FDA does not provide much direct guidance to companies. Instead, businesses must properly interpret the FDCA and government rules and regulations. These include, but are not limited to, the rules and regulations covered in FDA's internal guidance for investigators, inspectors, and representatives. Therefore, they are also a valuable resource for businesses. However, companies still need to make judgments and strategic decisions regarding FDA compliance. At Corporate Investigation Consulting, our team of consultants brings centuries of relevant experience and works closely with our clients to help them identify, understand, and meet their FDA compliance obligations.