IND/NDA/BLA Process

Attorney-Advisors for FDA-Compliant Human Clinical Studies

OFW Law’s attorneys assist clients with development, submission, and approval requirements related to the conduct of human clinical research for drugs and biologic products including new chemical entities, well-characterized proteins, and antibodies. Our attorneys also have extensive experience with the development, submission, and approval of Investigational New Drug (IND) applications, New Drug Applications (NDAs) and Therapeutic Biologic Applications (BLAs). We have represented clients seeking approval for initial human clinical studies through the review of their Current Good Manufacturing Practice (cGMP), nonclinical toxicology, pharmacology, and the proposed clinical development plan. We also have been intimately involved in reviewing and advising the data and dossier information for NDAs and BLAs, including reviews of manufacturing, toxicokinetics, pharmacodynamics, safety pharmacology, pharmacokinetics, clinical studies as well as the Electronic Common Technical Document (eCTD) backbone. We are experts in assisting our clients in navigating this multiyear process.

For more information about our services, contact OFW Law’s Washington D.C. offices by telephone at (202) 789-1212 or complete our online contact form. We look forward to working with you.