What We Do
Pharmakey LLC Profile
Pharmakey LLC is a pharmaceutical development consulting 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
Program PlanningStrategic, technical, and regulatory direction for pharmaceutical development, including regulatory and development gap analysis
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Regulatory Affairs – US FDA submissions and communications/meetings
CMC -- small molecules, proteins and biologics (cells, viruses, plasmids); topical, oral, inhaled, and parenteral dosage forms;
process/manufacturing outsourcing in US, Europe and India through Phase 2
Preclinical research, including IND-enabling studies
Translational medicine, first-in-man and proof-of-concept clinical trials
- Writing/submission via eCTD of INDs/NDAs, documents/reports for the US FDA; regulatory submission life-cycle maintenance