Welcome To Bowman FDA Regulatory Consulting Group (BRCG)
Drugs & Biologics
Medical Devices
BRCG is a full service Regulatory Consulting Group that is passionate about helping small, medium and large Pharmaceutical, Medical Device and Bio-Tech Companies become highly successful
We have 4 main focuses
1. Regulatory Stragegies: Cost effective and time efficient regulatory, quality and clinical strategies
2. Regulatory Submissions: Successful preparation of cost effective and time efficient FDA electronic and paper
submissions such as: INDs, IDEs, ANDAs, 510(k)s, 505(b)(2)s, BLAs, NDAs and PMAs
3. Regulatory Compliance: Quick assessments of compliance status (Regulatory, Clinical and Quality) and
successful resolution of FDA compliance issues such as: FDA 483s, Warning Letters, Consent Decrees, Recalls
4. Due Diligence: High Quality Regulatory, Quality, Compliance and Clinical assessments for Venture Capital Firms
and growing businesses who need in-depth regulatory, quality or clinical expert knowledge about a company or
product line.
