Raw Drug Materials and APIs

• Raw Drug Material and Active Pharmaceutical Ingredients (APIs)
• Packaging Material
• Excipient, colorant, flavor, essence, or material used in their preparation

Services

• GMP Compliance Consulting
• DMF Preparation and Submission

BBC Training

Released FDA application training and GMP training courses on APIs

• FDA cGMP Compliance for Drug Products: Interpretation & Application
• FDA cGMP Compliance for APIs: Interpretation and Application
• FDA cGMP Compliance: Auditing
• FDA cGMP Compliance: Auditing (Sterile Pharmaceuticals)
• FDA cGMP Compliance: Laboratory Controls
• FDA cGMP Compliance: Batch Record Review & Investigations
• FDA cGMP Compliance: Qualification and Validation
• FDA cGMP Compliance: Computer System Validation