OFW Law advises our clients on every aspect of the regulatory process related to bringing a product to market, including: strategic planning and submission of dossiers for approval of New Drug Applications (NDAs), Investigational New Drug submissions (INDs), and Biologic License Applications (BLAs); clinical and nonclinical investigations; bioequivalency testing, labeling, chemistry, and manufacturing. Our drug practice is unique because we provide in-depth assistance beginning with the earliest development stages of drugs and biologics, continuing with the drafting and filing of approval applications for investigations, facilitation of final approvals of both innovator and generic drugs, and counsel regarding the post-approval regulation of marketing and manufacturing of the product.
Highlights of our practice include:
At OFW Law our attorneys have handled more litigation involving FDA and generic drug approval requirements than any other law firm. When protection of market exclusivity becomes an attempt to "game" the system, we help clients submit trade complaints to regulatory authorities.
We advise firms on marketing products under over-the-counter (OTC) tentative and final drug monographs, or as competitors to "old" drugs that are currently marketed.
We welcome you to read more on the primary areas of our Drugs, Biologics, and Controlled Substances Practice by following the links to related practice areas. Or contact OFW Law for more information about our services.