SRC Sample Projects

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

     Medical Device

• 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.