Preclinical Toxicology and Regulatory Consulting Sample Projects:
Drug, OTC, and Cosmetics
- Gap analysis and due diligence for venture capital company investment candidate (CMC, preclinical, clinical and regulatory consulting)
- Literature review and manuscript preparation for a new dermal product
- Prepared the nonclinical safety section for a US IND and European CTD
- Toxicology laboratory selection and program oversight for a new cosmetic
- FDA submission for Rare Pediatric Disease Designation, granting a future voucher
- FDA submission for Orphan Drug Designation in the US and EU.
- Chemistry, Manufacturing and Controls (CMC) data review for new drug in development.
- Labeling and manufacturing review for OTC drug compliance
- Pre-IDE Briefing Document preparation and meeting management with the FDA for 3 different medical devices.
- SOP writing and quality system design for a medical device start-up company
- Defined FDA-required testing and device design requirements for a new drug injection system.
- Assisted in design of new manufacturing facility for lab-on-a-chip product, and defined and wrote required SOPs.