For pharmaceutical, biotech, and medical device manufacturers, as well as CDMOs and other FDA-regulated businesses developing or commercializing new products, FDA and healthcare regulatory compliance is always a top priority. With thousands of complex government regulations to monitor and comply with, you need a trusted FDA and healthcare regulatory attorney who can help you successfully navigate healthcare laws, regulations, and guidelines.
At Morningstar Law Group, our experienced team of FDA and healthcare regulatory lawyers advise pre-commercial startups, newly commercial-stage companies, and established industry leaders on compliance issues related to FDA and healthcare rules, regulations, and guidelines, state and federal fraud and abuse laws, and more.
Our attorneys, which include former general counsel and chief compliance officers, have served as lead counsel to small, mid, and large manufacturers, both U.S.-based and international, with generic and branded products and related issues. We understand the pressures involved with developing and launching new products and provide practical legal advice to guide you through the process efficiently and effectively.
FDA and Healthcare Regulatory Services
Developing and maintaining a clear understanding of FDA and healthcare regulatory requirements and guidelines is critical to ensuring successful product development and commercialization. Our FDA and healthcare regulatory lawyers assist clients on a variety of matters, including:
- Marketing, advertising, and sales materials
- Contracts necessary to develop and commercialize products in the United States
- Compliance programs (e.g., code of conduct, policies, SOPs, training)
- Payer contracts (e.g., rebates, data)
- Specialty pharmacy (and other) services agreements
- Wholesaler, distributor, and GPO agreements
- Internal investigations
- Post-marketing safety reporting/pharmacovigilance
Advice on other Federal Agencies
In addition to FDA rules, regulations and guidelines, Morningstar Law Group’s FDA and healthcare regulatory compliance attorneys advise clients on the rules, regulations, policies, and related enforcement landscape of other federal agencies, such as:
- Federal Trade Commission (FTC)
- Department of Health and Human Services Office of the Inspector General (OIG)
- Department of Justice (DOJ)
- Centers for Medicare and Medicaid Services (CMS)
Our attorneys also assist clients with challenges brought before the National Advertising Division of the Better Business Bureau.