• 1230 Colombia St, San Diego CA 92101
  • Free Consult(619) 770-9000

Serivces Details

Regulatory Affairs

BCVS supports Pharmaceuticals, Biologics, Medical Devices, Combination Products, and Active Pharmaceutical Ingredients (API) to achieve the most cost-effective way to undertake their regulatory activities worldwide. This includes regulatory intelligence and strategy, worldwide product registration, preparation of regulatory documents, in country representation, establishment registration, and post-approval submissions.

At BCVS, we believe sound regulatory planning is the key to success in achieving optimal time-to-market of quality products. Over the years, our experts have facilitated timely license approvals and streamlined the development process of exceptional products from start-up to post-marketing compliance for various clients.

  • Product Assessment
  • Device Classification
  • Investigation New Drug Application (IND) (Pharma, Medical Device)
  • New Drug Application (NDA/NDS)/Abbreviated New Drug Application (ANDA/ANDS)
  • Biologics License Application (BLA)
  • Premarket Approval (PMA) Application
  • Premarket Notification (510(k)
  • CMC Preparation
  • Periodic Safety Update Report
  • Mandatory Problem Reporting, Adverse Reaction Reporting
  • Review label and promotional materials
  • Review drug ingredients
  • Master File Preparation (DMF, SMF, MFA and VMF)

How can we help?

Schedule a free, no obligation consultation with one of our experts. With over 700+ employees dedicated to this industry across different regions in the world, we offer full time, part-time resources as well as managed services offerings to address your needs.