Regulatory Affairs Solutions
BGF offers a wide array of Regulatory Affairs solutions and can provide your organization with assistance to ensure regulatory filings, inspection responses, corrective action plans and communication with regulatory agencies meets compliance requirements and supports your critical business objectives. Our consultants have extensive experience with preparation and review of regulatory filings and in depth knowledge of FDA expectations and regulations. Additionally, BGF has hands on experience successfully preparing for managing and responding to regulatory inspections.
Key Services
Preparation & Review of Regulatory Filings
- IND, NDA, ANDA, BLA, 510K, Supplements, etc.
- Deficiency Responses
- Design Review of CMC Plans & Processes
Regulatory Interaction
- Inspection Readiness Preparation
- Response Preparation for 483, Warning Letters & EU & MOH inspection observations
- Inspection Management
- Compliance Remediation Plan Development & Implementation
Pharmacovigilance Activities
- Adverse Event Reporting
- Medical/Technical Literature Search & Analysis
Development of Regulatory Strategy
Labeling & Promotional Material Review
Regulatory Gap Assessment of Drug, Medical Device, and Biologic Products & Process
Manufacturing Process Evaluation & Optimization
Screening & Oversight of CTOs & CMOs
Annual Product Report & Review Compilation


