Compliance Management & Auditing Solutions

BGF can provide your organization with the resources you need to stay abreast of the increasing regulatory scrutiny around vendor auditing.  Our consultants have a large band with and direct experience with both foreign and domestic API and excipient manufacturers, contract manufacturer organizations, component and labeling suppliers, as well as other GMP vendors.  Additionally, our team of audit professionals can assist in conducting internal audits and help prepare your organization for a successful regulatory inspection.

Key Services

Compliance Gap Analysis & Remediation Plans

Inspection Readiness

• Pre-Approval Inspection Audit
• Mock FDA & EU Compliance Audit
• Mock ISO Inspections
• Inspection Readiness & Personnel Interaction with Regulatory Investigators

Supplier Auditing

• Contract Manufacturer Compliance
• API & Excipient
• Packaging & Labeling Supplies
• Component Manufacturers

Service Provider Auditing 

• Metrology Services
• Sterilization Services
• Aseptic Garments & Supplies

Internal Auditing

• FDA Systems Auditing
• Aseptic Qualification & Suitability 
• Gap Analysis for Recurring Issues & Negative Trends

cGMP/Quality Assurance Controls

• Standard Operating Procedures
• Master Batch & Device Records
• Corporate Policies
• Environmental Monitoring Programs
• Utility Sampling Programs
• Trend Analysis
• Management Review
• Change Control
• Development of Laboratory Methods