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

Services/Capabilities:

• 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