Pharmaceuticals, Small Molecule, and Biologic/Biotech Drugs

FDA Regulatory Hero Image.

We bring experience in every phase of the regulation of small molecule and biologic/biotech drugs — both prescription and OTC — for your business, including pathway advice (e.g., clinical trials), regulatory and compliance issues relating to bulk and finished prescription and OTC drugs, approvals, advertising, marketing, and distribution. In addition to providing advice relative to FDA and Federal Trade Commission (FTC) implications of these products, we also have substantial experience in counterpart regulatory systems in the EU, Japan, Korea, China, and other markets.

Our product-development and testing capabilities for your business include preparing pre-IND meeting requests, preparing for and leading pre-IND meetings between sponsors and FDA, and resolving issues that may arise in the IND process. FDA team members have specific experience in evaluating drug product formulations for conventional human and animal drugs, and the cell technology in biotechnology-produced drugs. We can assist with your clinical research issues, informed consent matters, and review and approval with IRBs.

With strategies designed to maximize your protection of a product or process idea, we have the experience and the skills to help you make your product a commercial success, including the licensing or sale of IP assets. We also have extensive experience addressing issues that affect generic drugs, including FDA’s “Orange Book,” patent extension and marketing exclusivity, bioequivalence determinations and related competitive disputes, state formulary matters, and those that can arise with pharmacy and therapeutic committees.