SRC Recent Projects

 

Preclinical Toxicology and Regulatory Consulting Recent Projects:

     Drug, OTC, and Cosmetics

  • Gap analysis and due diligence for venture capital company investment candidate (CMC, preclinical, clinical and regulatory consulting)
  • Clinical program management for a topical drug (Protocol design, IRB, IC, CRA auditing)
  • Literature review and manuscript preparation for a new dermal product
  • Feasibility study for new OTC drug candidate (Time & Extent Application)
  • Prepared the nonclinical safety section for a US IND and European CTD
  • Toxicology laboratory selection and program oversight for a new cosmetic
  • Project management for development of oral dose forms for 3 APIs.

     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.
  • Prepared a PMA for a new in vitro diagnostic marker for stroke
  • Assisted in design of new manufacturing facility for lab-on-a-chip product, and defined and wrote required SOPs.

 

Medical Writing Recent Projects:

  • Six articles and review manuscripts published in areas of aging skin, the physiology of the menstrual cycle, hormonal effects on dermal changes, and more (2009 – 2010).
  • Recently published articles in the following peer reviewed journals:  Contact Dermatitis, American Journal of Clinical Dermatology, British Journal of Dermatology, Infectious Diseases:  Research & Treatment, and Cutaneous & Ocular Toxicology.
  • Recent review articles for CME credits published in Obstetrical and Gynecological Survey, 64 (1), 58-72, 2009
  • Our medical writers wrote hundreds of Serious Adverse Event patient narratives.
  • Our experienced medical writing team supports the regulatory team on all regulatory submissions.