Bio Analytical
     MTR offers you extensive bio-analytical services in drug development by conducting analysis ranging from evaluation of drugs in Preclinical samples to that in Human trials. We have put together a team with strong scientific knowledge combined with the latest automated equipment to meet the needs of our clients. Our laboratories are GLP certified.

     Our ability to undertake studies for special population & unconventional molecules sets us apart fromthe competition. The bio-analytical department with entry/exit access controls has a carpet area of approximately 2000 Sq. ft

     MTR’s expertise in performing BA/BE studies is based on several years of scientific study conduct. Our dedicated study project teams are guided by significant clinical experience for various study types and therapeutic areas. Our clinics offer a complete set of bioequivalence services from our experienced physicians and support staff. Staffing for every sponsor program includes a dedicated project manager, rigorous quality control and quality assurance to ensure data integrity and timely report delivery.

     MTR is your partner with flexible Phase I / Bioequivalence resources at our two clinical locations in Chennai and one location in coimbatore, India. In addition to having common SOPs for each of our clinics, initial and ongoing training modules universally support each of our clinical operations.

     MTR provides full range of BA/BE services - Study design, protocol preparation, Ethics committee review submissions, selection of subjects, IP import, Sample export, pharmacokinetic and statistical data evaluations, study result report preparations and archival of study data documents.
Dosage forms - tablets, capsules, suspension, suppository, topical Immediate and modified release formulations
Trans dermal patches ­­­
    Studies in special populations
Light-sensitive compounds
Food effect studies, apple sauce studies
Multiple dose steady state studies
Studies in cancer patients
Dose escalation studies
Repeat ‘first-in-man’ studies
Clinical end point studies










 

Deep Freezer Room: Access controlled room with deep freezers. Enough space is provided for storage and retrieval of samples.

Sample Processing Area: Ten sample processing work-stations to handle samples independently. Equipment like solid phase extraction systems, refrigerated centrifuges, Millipore water purification systems, pH meters etc are accommodated in the sample processing area. Fume hood area for volatiles handling.

Instrumentation Room: Equipped with ten high throughput LC-MS/MS systems including water XEVO TQMS and AB SCIEX TRIPLE QUAD 5500 systems, with 21 CFR part II compliance software.

Analytical balance room: Air current and vibration free installation - semi-micro and micro balances

Chemical Storage Room: Adequate space is provided for the storage of chemicals/solvents in the chemical rack.

Washing Area: Exclusive room for washing glass wares with hot water. Hot air oven is accommodated to dry the glass wares.

Safety: Emergency shower and eye wash are provided near the sample processing area.

Buffer Area: Provides enough space for lockers for change of clothing, footwear and protective goggles before entry into the bio-analytical lab

Dark Room: To handle light sensitive drugs and metabolites