Pharmakey, LLC

Pharmaceutical ManufacturingNorth Carolina, United States2-10 Employees

Pharmakey is a Pharmaceutical Drug Development and Regulatory Consulting firm with an area of focus on IND, NDA, ANDA, MAA, BLA and 505(b)(2) eCTD Publishing and Submissions.

CONSULTING:
We provide nonclinical, clinical, and CMC services for your drug development programs.
  - Pharmaceutical Development Consulting
  - Outsourcing and Implementation
  - Regulatory Consulting 
  - Electronic Regulatory Publishing and Submissions
  - Due Diligence Consulting

We can assist  in development of a broad range of dosage forms, including tablet, topical, pulmonary, and parenteral products. Most of the drug development consultants and regulatory consultants at Pharmakey have at least 20-years experience, and have executed numerous drug-development projects in support of new and active INDs. 

eCTD PUBLISHING AND SUBMISSIONS
Our Electronic Regulatory Publishing group provides Document Report Level Publishing,  Regulatory Submission Level Publishing, and Document and Submission Quality Control. Our team uses the Lorenz eCTD system. All of our publishing staff are American citizens located in the USA. Since our inception we have never received a technical rejection. Our clients praise our Quality, Customer Service and Responsiveness.

Our company website lists our phone number and has a contact page so that you may write us with any questions or request a proposal.

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