Regulatory Strategy & Dossier Preparation

NGT’s regulatory experts 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 work seamlessly with other functional areas, such as 
Preclinical, Clinical, CMC, and Quality/Compliance. NGT capabilities in Regulatory Strategy and Dossier Preparation include, but are not limited to:

Preclinical and Clinical Drug Development
Additional Services

NGT Biopharma Consultants works closely with a network of regulatory submission publishing companies to facilitate the submission of high-quality information to Health Authorities.