Regulatory Affairs

Our regulatory strategy development and execution specialist provides regulatory services and strategic consulting to developers and manufacturers of medical devices, pharmaceuticals, biologic products and combination products. Her goal is help clients achieve compliance with the Food and Drug Administration (FDA) and other regulatory bodies (Europe, Health Canada) while using the most efficient and streamlined approach to product registration and marketing in the U.S. and abroad.

Our specialist assists manufacturers in assessing regulatory requirements and in writing regulatory documents (e.g., Premarket Notification or 510(k) applications, Premarket Approvals, de Novo Classification and Investigational Device Exemption applications; European Technical Files and Design Dossiers; Health Canada Medical Device Licensing applications). Our specialist assists clients at FDA meetings and in communications with the Agency to achieve understanding about planned product development and FDA expectations.  She also oversees project management and acts as the conduit between parties in the development process.

Our specialist also assists in determining compliance with Quality System Requirements or Good Manufacturing Practices and post-marketing requirements for medical devices including software, pharmaceuticals, biologic products and dietary supplements, including site audits. Our specialist is actively involved in the firm’s clinical trial design and management projects, including protocol development, Institutional Review Board (IRB) interactions, and Good Clinical Practice (GCP) monitoring. She serves as the U.S. agent for several foreign medical device manufacturers in Canada and EU and provides research, scientific writing and document support to medical or scientific firms.  Our specialist is located in Northern Virginia and convenient to FDA Headquarters.