SITEC LABS PVT. LTD., an ISO 9001:2008 Contract Research Organization (CRO), was founded in Dec 2004 with the motto of providing highest quality standards in the field of Bioequivalence, Analytical Research and Impurity Synthesis. Our strength is providing end to end solution in Clinical and Analytical Area for Pharmaceuticals. We also provide consultancy services in the above stated area.
Analytical and compendial analysis
- A fully GLP compliant 20,000 sq. ft. state-of-the-art Analytical Research facility.
- It is well equipped with many sophisticated analytical instruments like MALVERN PARTICLE SIZE ANALYZER, SYMPHATEC PARTICLE SIZE ANALYZER, GC, GC-MS,IC, ICPMS, 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.
- Analytical data management systems, meeting to the needs of 21CFR Part 11 compliance.
- Inspected and approved by USFDA.
- A fully GCP compliant Bio-Clinical centre occupies a spacious modern building over 12,500 sq. ft. of area.
- Bioequivalence Division is well equipped and has experienced staff to undertake Bioavailability / Bioequivalence / Pharmacokinetics projects of any kind.
- With vast experience in conducting studies in specialized formulations like Sprays- Nasal & Oral; Inhalers and Dermal patches.
- Providing comprehensive product development and post-approval services for biopharmaceuticals and devices.
- A state-of-the-art Bio-analytical facility occupies about 12,500 sq. ft. of space and comprises labs for sample processing, instrumental analysis and sample storage.
- Generations of LCMS/MS instruments like SCIEX API 6500 that provide the flexibility to develop and execute the analysis in wide range of sensitivity (µg / ml to fg / ml).