Regulatory Affairs

Guided by our own in-depth knowledge of the integrated drug development process, B&H can partner or lead your regulatory efforts across a product's life-cycle at both the strategic and operational levels.

• Provide expert advice on regulatory strategy 
• Prepare and implement regulatory Standard Operating Procedures
• Prepare, review and assemble investigational applications, including verifying and evaluating documentation.
• Handle day-to-day regulatory operations. Tasks include but are not limited to:
  • Prepare information and protocol amendments, individual case safety reports and all necessary correspondence to FDA
  • Audit investigator documentation to ensure compliance with 21 CFR 50 and 21 CFR 56 
  • Prepare export documentation for non tier-one countries; assure all appropriate export documentation is in place for tier-one countries
  • Manage labeling changes for USPI, SmPC and Core Data sheet
  • Review study protocols, study reports, and completed CRFs for submission accuracy/  
    completeness
• Prepare meeting requests and background documents in advance of sponsor meetings with Health Authorities  
• Prepare, review and assemble marketing submissions to Global Regulatory Authorities for the following product categories: 
  • Drugs, including orphan drugs and fast track applications
  • Generic drugs
  • Devices, including diagnostics and combination products
  • Biologics
  • Veterinary products
• Liaise with health agencies to resolve issues and expedite marketing approvals
• Prepare/submit electronic Drug Establishment Registration/Renewals and Drug Product Listings (eDRLS)
• Manage/input study information in FDA database (clinicaltrials.gov) for investigational protocols