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Services Rendered

We, Sitec Labs Pvt. Ltd., offers world class solution in the domain of Bioavailability/ Pharamcokinetics/ Bioequivalence, Bio-analytical Research, etc. We render following services:
  • Analytical Method Development & Validation
  • AAS Elemental Analysis
  • Analytical Research Services
  • Stable Isotope Analysis Services, Deuterium Isotope Analysis Services
  • Bio Analytical Chemical
  • Bioavailability & Bioequivalence Studies
  • Credentials Services
  • Custom Synthesis Service
  • Generic Products Analytical Development Services
  • Herbal Extracts Characterization
  • Inhalation Products Specialized Testing Services
  • Ovi's & Investigational Analysis Services
  • Pharmaceuticals/ Products Comparative Evaluation Services
  • Quality Assurance Service
  • Regulatory & Credentials Services
  • Regulatory Affairs Services
  • Regulatory Compliance
  • Text Analytical Services
Quality

Sitec QA team is engaged in direct interaction with the clients in order to understand their specific requirements for clinical study or drug development project. Further, our quality & regulatory affairs specialists make sure that all stages of study are in conformation to client requirements & any applicable regulations like DCGI, MCC, EMEA, WHO, US-FDA Regulations. The vast experience and oversight in this field help us ensuring that our clinical and bio-analytical services comply with applicable Good Laboratory Practices (GLP), Good Clinical Practices (GCP) & International Conference on Harmonization (ICH) GCP guidelines (E6).

We are committed towards continual improvement, and thus measure, assess & report quality data as well as seek ways to improve quality performance. Our corrective & preventive action (CAPA) process ascertains that we investigate significant out-of-specification events, discrepancies and deviations, report findings/ conclusions of the investigation, and then implement corrective measures.

Our Quality Assurance Services include Auditing, Validation, and Regulatory Inspections.

Our Facilities

Our company is equipped with latest facilities for Analytical & Competent Analysis, aiding us in rendering quality approved services. The details are as give below:
  • Our sound Analytical Research Facility is in compliance to CGMC and is spread over 20,000 sq. ft.
  • Analytical data management systems that meet the needs of 21CFR Part 11 compliance
  • The Research Facility is outfitted with advance instruments like Symphatec particle size analyzer, MALVERN particle size analyzer, GC,GC-MS,IC, ICP-MS, AAS, XRD, DSC, TGA, CHNS- O, HPTLC with 3-D imaging technique, Fluorescence, HPLC with various detectors like UV-VIS, electrochemical, PDA detectors, refractive index, etc.
  • Our facility is authorized by USFDA.
Bio Analytical & Bio-clinical

Our sound Bio-analytical facility covers about 12,500 sq. ft. of area and comprises labs for sample processing, instrumental analysis as well as sample storage.
  • We have developed a state-of-the-art bio-clinical center that is in compliance to GCP.
  • Our facility is equipped with LCMS/MS instruments that provides great flexibility to smoothly develop and execute the analytical operation (µg / ml to fg / ml).
  • Offering comprehensive product development & post-approval services for bio-pharmaceuticals and devices.
  • Years of Expertise and vast knowledge of our professionals to examine specialized preparations like Sprays- Nasal and Oral; Inhalers & Dermal patches.
  • Well equipped SITEC Bioequivalence Division backed by experienced staff to undertake Bioequivalence/ Bioavailability/ Pharmacokinetics projects of any kind.
  • Inspected and certified by DCGI, MCC, EMEA, MoH UAE, WHO & US-FDA, MoH SUDAN.
  • NABL Accredited in-house Pathology Laboratory.