Sitec Labs Private Limited

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Listed in Clinical Development - Ph I

  • PEE – DEE Infotech, Plot No.: GEN – 40, TTC, MIDC Behind Millennium Park, Near NELCO, Mahape, New Mumbai, India

Sitec is a Contract Research Organization with a global infrastructure that allows us to conduct in-vitro and in-vivo studies. For pharmaceutical, biotechnology, generic drug, and medical device companies of all sizes around the world.

Sitec can conduct your Phase I clinical trials, Bioequivalence/Bioavailability/Pharmacokinetics studies in virtually all therapeutic areas, quickly and efficiently in healthy and special populations. Our extensive database ensures rapid study participant recruitment.

Sitec scientists have the expertise to solve the most complex bio-analytical problems, for small or large molecules, using techniques from LC/MS/MS and biomarkers.

Sitec is well equipped with many sophisticated analytical instruments like MALVERN particle size analyzer, Symphatec particle size analyzer, GC-MS, ICP, AAS, XRD, DSC, TGA, CHNS- O, HPTLC with 3-D imaging technique, HPLC with various detectors like UV-VIS, Fluorescence, electrochemical, refractive index, PDA detectors etc. Our Analytical data management systems, meets the needs of 21CFR Part 11 compliance. Laboratory have all the required equipments like Cascade impact or Twin Impigner, Uniformity of delivered dose apparatus etc., to perform analysis of pressurized Metered Dose Inhaler (pMDI), and Dry Powder Inhalers (DPIs). State-of-the-art Microbiological testing facility for Microbial Limits Tests, Bioassays, Sterility etc. With the help of talented research technicians and scientist and specialized instrumentation, SITEC LABS continuously works towards new innovative approaches to analytical testing. We are expert in performing Method validation and forced degradation studies and so far have done more than 2000 + studies for various pharma companies both national and international repute. State-of-the-art Custom Synthesis facility with sophisticated instruments like All glass reaction vessels (2 L to 20 L), Rotavapors, Lyophilliser, Flash Chromatography, Diaphragm Vacuum Pump upto1mm, Microwave Synthesizer CEM, and Preparative HPLC.

Our research professionals includes, Clinical Pharmacologist, Registered Pharmacist, Physician Registered Nurses, Phlebotomists, Biostatisticians, Clinical and Analytical researcher who have a rich wealth of experience in this demanding field and ensure that the services, data and reports meet the highest standards as, meeting to the ever demanding regulatory requirements.

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