Regulatory & Toxicology



LEC Associates provides assistance in the preparation and writing of SPL, NDC, NDA review and interpretation of toxicology study data and pharm/tox guidance.


  • SPL NDC, IND, ANDA, NDA preparation for FDA drug filings
  • Annual report and submission
  • SIte Establishment Registration
  • OTC label reviews
  • Canadian DIN & NHP Submission
  • Subcontracting and monitoring of preclinical work (acute, subchronic, chronic)
  • Placement and oversight of clinical studies (Phase I, II, II)
  • Qualification and placement of analytical/contract manufacturing facilities to fulfill CMC requirements
  • Project management support of drug development