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Typical Questions Facing Small Biotech or Start-Up Companies

  • Does the API or the drug substance (NME) used in the IND enabling GLP nonclinical studies have to be cGMP grade material?
  • Is it a CMC hold issue if the API (NME) used in the IND enabling GLP studies is not representative of API material proposed to be used in the FIH Phase 1 clinical study?
  • Is the determination of a no observed adverse effect level (NOAEL) or no effect level (NOEL) in the nonclinical IND enabling Tox studies absolutely essential for a NME proposed for oncology FIH phase 1 study?