Sitec Labs Ltd., established in 2004, is a leading Clinical Research Organization (CRO) that provides comprehensive clinical research services to the biopharmaceutical and generic pharmaceutical industries. It has been inspected and approved by DCGI-India, US-FDA, WHO, MHRA-UK, EMEA-European Union, ANVISA-Brazil, GCC, and many other regulatory authorities.

The facility is located at Mahape, Navi Mumbai. It is spread over 75,000 sq. ft. with operations such as clinical, bioanalytical, pharmacokinetic & statistical analysis, medical writing, quality assurance, and is designed to meet global regulatory requirements. The centre boasts state-of-the-art infrastructure, including dedicated clinical facility with 112-beds, and a diversified database of more than 15,000 volunteers, it provides contract research services in bioavailability and bioequivalence studies in healthy volunteers of simple and complex generics.

In addition, it also has a fully GLP compliant bio-analytical facility having laboratories for sample processing, analysis and sample storage. It has 24 LCMS/MS instruments that provide flexibility to develop and execute the analysis with wide range of sensitivity (μg/mL to fg/mL). There are experienced professionals to conduct BA/BE studies on healthy volunteers for all kind of respiratory and non-respiratory drug formulations e.g. solid oral formulations (IR and MR), liquid formulations, injections (IM, IV, SC, Implanrs), chewing gums, lozenges, transdermal patches, nasal sprays, and orally inhaled drug products (pMDI, DPI, and nebulizers) etc.