Regulatory Strategy & Application Preparation
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:
PRECLINICAL AND CLINICAL DRUG DEVELOPMENT
- Assess IND-enabling studies for submission readiness
- Establish a local or global regulatory strategies, including plans for leveraging expedited pathways and special programs
- Optimize, create and submit meeting requests, meeting packages and briefing books
- Provide IND and CTA maintenance (initial submissions, amendments, annual and periodic reports and closure
REGISTRATION
- Prepare companies for Pre-NDA meetings and scientific advice
- Create and manage Emergency Use Authorizations submissions
- Provide NDA/BLA/MAA dossier authoring and regulatory project management
- Priority review requests
- Managing responses to health authority questions
ADDITIONAL SERVICES
- U.S. Agent for non-U.S. entities
- Regulatory due diligence, gap analyses and risk management
- Rare Pediatric Disease Designations
- Special Protocol Assessments
- Expedited program requests (Breakthrough, Fast Track, Priority Review, Accelerated Approval)
- Orphan Drug Designations
- Regulatory strategy refinement and optimization
NGT Biopharma Consultants work closely with a network of regulatory submission publishing companies to facilitate the submission of high-quality information to Health Authorities.
