Bioequivalence Trials

	Galeno Research (Galeno Desenvolvimento de Pesquisas Ltda.) is an accredit CRO in Brazil authorized to conduct all the steps of bioequivalence trials (planning, clinical, analytical and statistical services). Galeno has performed more than 300 bioequivalence trials since its beginning).

Analytical Services

	Running only LC/MS-MS systems (API 4000, API 3000, Quattro Micro), more than 200 analytical methods have been developed and validated according to the Brazilian and FDA rules, during the last 10 years. Analytical services are provided for regulatory submissions (bioavailability/bioequivalence protocols), as well as basic research.

Clinicaland Pre-Clinical Trials   Galeno conducts Phase I, Phase II, Phase IV, including “proof of concept” trials, counting with a 24 bed hospital unit and Intensive Care Unit for emergency situations. Galeno’s staff has a large experience in conducting clinical trials, since 1991. Besides clinical trials, Galeno counts with a support team and facilities to run pre-clinical tests, including toxicological tests in animals in accordance with good laboratory practices.

Statistical Services    Pharmacokinetics and bioavailability analyses are also provided using industry standard software (e.g. WinNonLin ™). Statistical and final study reports provide all the clinical, pharmacokinetics and statistical data required for regulatory submissions.