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+54 11 4775-2640 / 2869

Inspections

Sistema de Gestión de Calidad

   Authorized by A.N.M.A.T.


  • F.P. Clinical Pharma has received the authorization from Argentinian MoH - A.N.M.A.T., for the execution of clinical studies in the area of Pharmacokinetics, Phase 1, Bioavailability and Bioequivalence at its Clinical - Pharmacokinetic Research Unit.
  • Argentinian MoH [I.N.A.M.E.; A.N.M.A.T.] has inspected and authorized the Bioanalytic Laboratories that work for F.P. Clinical Pharma for the development and validation of bioanalytical methods for analite/s quantification.
  • Authorized by Chile MoH – I.S.P.; as a Center for conducting Bioequivalence Studies with recognition in that country.

Therefore; FP Clinical Pharma’s studies are recognized by the Health Authority of Chile and are accepted to support medicinal products registration.

The authorization is valid for 3 years.


Santiago, Chile, September 5, 2011:-The National Agency of Drugs, Institute of Public Health of Chile through Exempt Resolution #1660 recognized for F.P. Clinical Pharma SRL as a CENTER OF BIOEQUIVALENCE STUDIES for the conduction of clinical, bioanalysis (analysis of drugs in biological fluids) and statistics (statistical analysis/ pharmacokinetics) of studies in bioequivalence.

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Professionals of our staff will attend giving all necessary advice.

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+54 11 4775-2640 / 2869