Blood, Blood Products and Vaccines...

FDA Application and GMP Consulting

Blood, Blood Products and Vaccines...

• Blood
• Blood Products
• Vaccines
• Gene Therapy

Services

• GMP Compliance Consulting
• GLP Compliance Consulting
• GCP Compliance Consulting
• IND Preparation and Submission
• Clinical Trials Design and Execution
• Registration of Establishment
  • Blood establishment
  • Tissue and human cell establishment
• BLA Preparation and Submission

BBC Training

Released training courses on FDA application training and GMP training:

• cGMP: Interpretation & Application (Drug Products)
• cGMP: Interpretation & Application (BPCs & APIs)
• cGMP: Compliance Auditing
• cGMP: Compliance Auditing (Sterile Pharmaceuticals)
• cGMP: Laboratory Controls
• cGMP: Batch Records Review and Investigations
• cGMP: Qualification and Validation
• Computer System Validation and ER/ES
• FDA Regulations: New Drugs & Generic Drugs
• cGCP: Interpretation & Application
• Design and Analysis of Clinical Trials
• Principles and Applications of Pharmacoeconomics

* Click "here" for all BBC courses on FDA application and GMP training