Beaufort, LLC, is a clinical research organization that helps develop and implement customized regulatory strategies designed to optimize the development of investigational drugs and to reposition or expand the market for existing pharmaceuticals. With experience in IND, NDA, orphan drug, and EMEA submissions in the U.S. and around the world, Beaufort’s expertise is trusted by top pharmaceutical companies.
Beaufort can lead a project from beginning to completion or we can provide stand-alone services that complement your internal and other resources. This flexibility enables us to provide the appropriate combination of services and solutions whether your pharmaceutical company is large, emerging or considering its first entry into the U.S. market.
Pharmaceutical Regulatory Consulting Services
Beaufort offers a broad range of pharmaceutical consulting services for regulatory strategy and compliance in multiple therapeutic areas. Our regulatory consulting services include:
- Regulatory strategies
- Pre-IND submissions and meeting preparation (scheduling, information package development, presentation assistance, and FDA mediation)
- Protocol design
- IND applications
- NDAs, aNDAs
- 505(b)(2)s
- Orphan drug applications
- Liaise with FDA and European authorized representatives
- Annual reports
- Post-market support
- Drug master file
- Regulatory training
