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 Bioavailability / Bioequivalence / Pharamcokinetics, Bio-analytical Research, Analytical Research and Custom Synthesis. Our strength is providing end to end solution in Clinical and Analytical Area for Pharmaceuticals, food and Herbal products worldwide. We also provide consultancy services in the above stated area.
- A fully cGMP compliant 25,000 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-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.
- Analytical data management systems, meeting to the needs of 21CFR Part 11 compliance.
- A fully GLP compliant Bio-analytical facility occupies about 12,500 sq. ft. of space and comprises labs for sample processing, instrumental analysis and sample storage.
- LCMS/MS instruments that provide the flexibility to develop and execute the analysis in wide range of sensitivity (µg / ml to fg / ml).
- A fully GCP compliant bio-clinical centre occupies a spacious modern building over 10,000 sq. ft. of area.
- Providing comprehensive product development and post-approval services for biopharmaceuticals and devices.
- SITEC Bioequivalence Division is well equipped and have 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.
- Successfully inspected and certified by DCGI, EMEA, MCC, MoH UAE, MoH SUDAN, WHO & US-FDA.
- In-house Pathology Laboratory