Bioanalytic Services
Cuantification of active principles and / or metabolites in biological samples for pharmacokinetic studies, bioavailability, bioequivalence, and phase I.
Cuantification of active principles and / or metabolites in biological samples for pharmacokinetic studies, bioavailability, bioequivalence, and phase I.
Our BioAnalytic Services include:
- Development of Bioanalytical methods under ANMAT regulations Provision 5040/06- 1746/07 and Guidance for Industry, Bio analytical Method Validation, FDA, CDER, 2001; EMA 2012..
- Analysis of biological samples for studies in bioavailability- bioequivalence.
- Analysis of biological samples for clinical studies (phase 1).
Other services
Clinical Studies - Phase I Studies
Clinical Studies - Phase I Trials
We conduct Phase I to IV Clinical Research studies with the highest quality standards. A team made up of Medical Specialists from our research units together with the team of Medical Researchers form a group in charge of developing the protocols.
View detailsBioavailability-Bioequivalence Studies
We are leaders of design, execution, and analysis of Bioavailability-bioequivalence and pharmacokinetic studies in Argentina
View detailsLATAM Pharmacovigilance
The team at FP CLINICAL PHARMA can help your company in developing a GOOD PHARMACOVILIGANCE PRACTICES PROGRAM according to your specific needs. THE GOOD PHARMACOVILIGANCE PRACTICES PROGRAM was designed as a quality system based on national and international guidelines and includes the investigation, detection, assessment, validation, monitoring, reporting and archiving of adverse events of the products during commercialization.
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