Pharmakey, LLC Email Format

PharmaceuticalsNorth Carolina, United States2-10 Employees

Pharmakey, LLC is a pharmaceutical drug development and regulatory consulting firm based in Durham, North Carolina, with a small team of professionals. The company provides nonclinical, clinical, and CMC services to support drug development programs, with a focus on IND, NDA, ANDA, MAA, BLA, and 505(b)(2) eCTD publishing and submissions. Its consultants bring substantial experience, many with two decades in the field, enabling work on new and active INDs.

Pharmakey can assist in developing a broad range of dosage forms, including tablet, topical, pulmonary, and parenteral products. Its Electronic Regulatory Publishing group provides publishing at both document and submission levels and conducts quality control using the Lorenz eCTD system, with a U.S.-based team and a record of no technical rejections since inception.

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