PRARD is an abbreviation of Professionals for Regulatory Affairs and Research & Development. We are professional team covering various specialties as shown below required for the R&D of drugs and medical products, supported by reliable advisors and partner companies having many years experience and specialties.
CMC (Specifications and Test Methods, Stability, GMP compliance, Process Validation, Biologics and Tissue Engineering Technology)
Clinical and Regulatory Affairs (Clinical Trials, Clinical Research, GCP compliance)
Submission and Regulatory Affairs (Documentation, Development Strategy, Medical Writing)
We collaborate with highly-experienced consulting firms outside Japan including followings in order to successfully assist the international projects timely and effectively.
Company Name
Location
Speciality
Beckloff Associates, Inc.
Kansas, USA
Regulatory Affair in US/EU
Pro-Active Translations, Inc.
N.Y., USA
Biomedical Translations Specialist
Vigilex B.V.
Holland
Pharmacovigillance in US/EU
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