Freyr Clinical and Nonclinical Services

Freyr provides comprehensive strategic services for NCEs, NBEs, Biosimilars, Generics, and Differentiated and OTC products through Nonclinical and/or Clinical development and registration across the globe. We deliver high-quality Medical Writing services for IND, NDA, NDS, BLA, MAA, ANDA, ANDS, 505B2, Generic, and Bibliographic submissions. Freyr’s Nonclinical Writing expertise includes developing Nonclinical Overviews and Summaries, IBs, and Briefing Books (for Pre-IND, PDM, and SAM meetings). In addition, we are proficient in developing and reviewing Nonclinical Study Protocols and Nonclinical Study Reports. Our Toxicologists have supported numerous pharmaceutical manufacturers on the development of Health Based Exposure Limits (HBEL) such as PDE/ADE and OEL, toxicological assessments of excipients, impurities, leachables, and extractable, flavors, and coloring agents.

Our Vision
“To be the essential partner to manage global Regulatory complexity and market safe and compliant products in local countries.”
In order to succeed, we must first believe that we can, and we strongly believe the future is not something we enter, it is something we create.
And we are here to create a compliant pathway for our customers’ global market entry.
Quick Facts
• 40+ REGULATORY EXPERTS
• 150+ PROJECTS
• 1500+ PDE REPORTS
• 50+ CLINICAL STUDY REPORTS
• 80+ CUSTOMERS