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