Building a sound regulatory strategy can be a challenging endeavor, especially for emerging biologics companies. Beaufort, LLC, is a clinical research organization that helps develop and implement customized regulatory strategies designed to optimize the development of biologics.
Biologics Regulatory Consulting Services
Our regulatory services include:
- Regulatory strategies
- Pre-IND meetings
- Protocol design
- INDs
- BLA and BLA supplement submissions
- Liaise with FDA and European authorized representatives
- Annual reports
- Post-market support
Biologics Specialties
- Gene therapy
- Preventative Vaccines
- Cancer Vaccines
- Allergenics
- Blood and blood components
