Pharmakey LLC Profile
Pharmakey LLC is a pharmaceutical development company based in Research Triangle Park, North Carolina.
The successful progression of a new drug, from candidate selection through clinical trials, is greatly dependent on making the right choices early in development. Our goal is to help you make the correct scientific and regulatory decisions the first time, and then execute the development plan that best suits your product and timelines. To achieve this, Pharmakey utilizes in-house knowledge and an extensive network of contract resources to bring custom-fit pharmaceutical solutions to each project. We deliver regulatory and development success, from preclinical stage through marketing application for new drug products.
Expertise
- Strategic, technical, and regulatory direction for pharmaceutical development.
- Regulatory Affairs: Writing/submission via eCTD of INDs/NDAs for the US FDA, and facilitating meetings with FDA.
- CMC, Nonclinical and Clinical development of small molecules, proteins and biologics (cells, viruses, plasmids): Outsourcing in US, Europe and India through Phase 2.
- Topical, oral, inhaled, and parenteral dosage forms;
- Technical and program-level supervision of development activities in support of processes for antibiotic, protein, and plasmid therapeutics at several CMOs
- Regulatory and Development Gap Analyses: Creating and Execution of Strategic Development Plans.
Founder
David R. Houck Ph.D.
Dr. David Houck is an accomplished chemist and drug developer with over 25 years of experience in the pharmaceutical and biotechnology industries. Dr. Houck assists companies to find efficient and successful solutions to challenges of new drug products. His technical expertise is formulation development, manufacture, and release testing of their therapeutic candidates for preclinical and clinical studies. Dr. Houck has pharmaceutical and biotechnology experience at Merck, Sterling Winthrop, OSI Pharmaceuticals, and Scynexis, and has authored/co-authored over 25 articles, and holds ten patents.