Regulatory Support

Pre-IND Support:

  • Explanation of CBER expectations and policies
  • Review of pre-clinical product development
  • Guidance on CBER interactions and meetings
  • CMC guidance
  • Pharm/Tox guidance

IND Support:

  • Review/Evaluation of pre-clinical data
  • Assistance in clinical trial design
  • Assistance in preparation for pre-IND meeting
  • IND preparation and review
  • Assistance in responding to CBER questions
  • Assistance in preparation of IND amendments and annual reports

BLA Support:

  • Review and evaluation of clinical and manufacturing data
  • Assistance in preparation for pre-BLA meeting
  • BLA preparation and review
  • Assistance in responding to CBER questions

Orphan Drug Applications

Drug Master Files

 

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