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New Drugs/Brand Drugs
FDA???GMP?????
New Chemical Drugs
New Biological Drugs
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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