Drugs (APIs, Brand and Generic Drugs)

FDA Application and GMP Consulting

Drugs (APIs, Brand and Generic Drugs)

• New Drugs/Brand Drugs
  • Chemical Drugs
  • Biological Drugs
• Generic Drugs
• Raw Drug Materials and APIs

New Drugs/Brand Drugs

• New Chemical Drugs
• New Biological Drugs

Services

• GMP Compliance Consulting
• GLP Compliance Consulting
• GCP Compliance Consulting
• IND Preparation and Submission
• Clinical Trials Design and Execution
• NDA Preparation and Submission

BBC Training

Released FDA application training and GMP training courses on new drugs:

• 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
• FDA Application Regulations: New Drugs and Generic Drugs
• FDA cGCP Compliance: Interpretation and Application
• FDA: Design and Analysis of Clinical Trials
• FDA: Fundamentals of Health Economics and Outcomes Research

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