NGT BioPharma Consultants’ regulatory experts in both small molecules and biologics (Mabs, duobodies, proteins, cell therapy, gene therapy, and other new modalities), leverage decades of experience developing robust regulatory strategies, managing regulatory agency interactions, and authoring regulatory documentation to provide clients with the most expeditious path to approval. We offer project management support and a ‘single point of contact’ interface with publishing vendors and CRO’s.
Our regulatory consultants also work seamlessly with other functional areas, such as Nonclincal, Clinical, CMC, and Quality/ Compliance. NGT BioPharma Consultants’ capabilities in Regulatory Strategy and Dossier Preparation include, but are not limited to the services highlighted below:
NGT Biopharma Consultants work closely with a network of regulatory submission publishing companies to facilitate the submission of high-quality information to Health Authorities.