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 submission management 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 Drug Development
Commercialization & Post-Launch
Early-Stage and Late-Stage Clinical Development

NGT Biopharma Consultants works closely with a network of Regulatory Submission Publishing companies to expedite submitting high-quality information to global Health Authorities.