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SITEC LABS PVT. LTD. was founded in December 2004 by a group of venture capitalists. It is in the business of providing Analytical solutions to the Pharmaceutical industry, Food industry, Healthcare & Industrial markets. It is also known to provide support in the field of Structural Elucidations, DMF filings, Method validation & Method development, BA/BE studies for Pilot, Pivotal, Proof of Concept, Steady state and more. |
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Recognition |
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SITEC LABS has been accredited by ISO 9001: 2000, analytical lab approved by FDA (Maharashtra). GCP certified lab by WHO, MCC (South Africa). BA/BE studies submitted has been audited and approved by USFDA.
Facility has been audited and approved by EMEA. |
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Campus |
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SITEC LABS PVT. LTD. is located at Vikhroli, an eastern suburb of the commercial capital of India, Mumbai. The 20,000 sq. feet facility houses a Bioclinical Centre, Bioanalytical Laboratory, GMP complaint Analytical Research Center, Administrative Offices. |
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Quality Assurance |
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SITEC LABS applies stringent tests of quality, through:
- Training of personnel.
- Review of SOPs, protocols and reports.
- Evaluation of external sites for clinical trials.
- Evaluation of systems.
- Archiving and data management.
- Facilitating audits by regulatory authorities.
- Qualification to ISO 9001 and international quality standards.
- Audits of unit operations.
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