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MICRO THERAPEUTIC RESEARCH LABS PRIVATE LIMITED

MTR Snapshot. MTR offers contract research services providing support to global Pharmaceutical, Biotech and Cosmetic industries in the areas of clinical and preclinical research to enhance their R

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MICRO THERAPEUTIC RESEARCH LABS PRIVATE LIMITED

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    1. MICRO THERAPEUTIC RESEARCH LABS PRIVATE LIMITED

    2. MTR Snapshot MTR offers contract research services providing support to global Pharmaceutical, Biotech and Cosmetic industries in the areas of clinical and preclinical research to enhance their R& D Success Founded in 2005, in Chennai, India Our fully air conditioned facility, spreads over 45,000 square feet, is one stop centre for BA/BE 16,000 square feet for Pre-Clinical & Analytical studies Operating with around 250 employees

    3. Vision “To be a Value Driven, Top Five International Healthcare Research Organization”

    5. OUR CORPORATE TECHNICAL STAFF

    6. Spectrum of Services Phase I – IV studies. BA/BE Pathology laboratory Bioanalytical. Clinical trial Clinical data management & pharmacovigilence. Preclinical Analytical

    7. Clinical Services 200 bed facility across Two locations. Synchronized clocks all over the facility. Bio waste segregation and management. 7 Beds ICU facility across the two locations. Tie up with hospitals to handle emergencies. Access controlled pharmacy with temperature and humidity control

    8. Volunteer Databank

    9. PATHOLOGY LABORATORY State of Art Laboratory equipped with sophisticated and fully automated diagnostic equipment capable of analyzing all the blood parameters. NABL and CAP accredited Laboratory Continuous participation in proficiency testing & EQAS

    10. INSTRUMENTS – PATHOLOGY LABORATORY Random access fully automated Biochemistry analyzer - 2No Selectra ProM & Vitros 250 (Dry Chemistry) Fully automated Immunoassay analyzer Vitros ECiQ Chemi Luminescence (Immuno Assay) Automated Haematology Cell with 5 part differential count. (SysmeX 800i & XT 1800i) ELISA strip reader and automated washer.

    11. EXPERIENCE IN BA/BE STUDIES

    12. REGULATORY AUDITS - STATUS

    13. Submission Studies (Pilot & Pivotal)

    14. CHART OF SUBMISSION STUDIES (PIVOTAL)

    15. BIOANALYTICAL INSTRUMENT

    16. Bioanalytical Instrument

    17. Clinical Trial - Patients

    18. Our Strength In Clinical Trials Investigator selection Study conduct Clinical study monitoring Clinical trial co-ordination Clinical trial site training Submission and Approval from DCGI for trials in India Investigational Product and Material accountability Site

    19. Clinical Data Management & Pharmacovigilance 21 CFR Part 11 compliance. SAS 9.2,WinNonlin 5.2.1,CDISC Standard Report formats (full eCTD / Partial eCTD) Argus Safety – Pharmacovigilance (Signal detection, Narrative writing and AE&SAE periodic reporting)

    20. Pharmacovigilance

    21. Preclinical Service Pre clinical facility in a total area of 7500 Sq.Ft with double corridor,Controlled Temperature and Humidity and light cycle is under construction. Completed more than 150 studies in compliance with OECD, Schedule Y, IP, BP, USP, NCCLS (CLSI) guidelines. Registered with “Committee for the Purpose of Control And Supervision of Experiments on Animals (CPCSEA)”. Ministry of Environment & Forests, Government of India. Registered with “Institutional BioSafety Committee” – Ministry of Science and Technology, Department of Biotechnology

    22. Pre Clinical Services - In Vivo Special Toxicity Studies Allergenicity test in Guinea pig Genotoxicity Micronucleus In vivo Chromosomal Aberration In vivo Toxicokinetics Pharmacokinetics Efficacy studies Antibacterial activities Other Toxicity Studies Abnormal Toxicity Pyrogen Test

    23. Pre Clinical Services - In Vivo Systemic Toxicity Studies Acute Toxicity Sub acute toxicity Sub chronic toxicity Chronic Toxicity Carcinogenicity Combined Chronic & Carcinogenicity Topical Toxicity Studies Dermal Toxicity Skin Irritation Ocular Irritation Reproductive Toxicity Studies Prenatal Developmental One-Generation Reproduction Two-Generation Reproduction Reproduction - Developmental Toxicity

    24. Analytical Chemical analysis of API, excipients and finished products in accordance with the physics-chemistry & microbiology in accordance to USP, BP, EP, JP and other Pharmacopoeias requirements Instruments Waters Alliance HPLC systems with UV & PDA. Dissolution apparatus with Auto sampler UV-Spectrophotometer. Stability chambers.

    25. Quality Compliance Robust SOPs. ISO and GCP compliant Prompt follow up & Resolution Dedicated, qualified & well trained experienced QA department.

    26. Archival Facility Total area -1145 sq.ft . Fire protection - With fire proof light and inert gas filler Electric shortages - With fire proof light and inert gas filler Electric shortages - With fire proof light and inert gas filler Archived Data Security - Fire proof compactors Soft data storage capacity- Tape drivers stored in Data safety cabinet for 15 years

    27. High lights of mtr MTR has Validated nearly 130 molecules at our Bio-analytical facility which includes challenging molecules like Vitamin D3 and its metabolite. Doxercalciferol and its metabolites Ethinyl Estradiol Estradiol and its metabolite Omega 3 –Fatty Acids and Esters Hormonal drugs MTR is the Pioneer to validate method for Nitroglycerin in LC-MS/MS system. MTR is the First CRO in India audited by USFDA for studies on Special Population (Post menopausal women) MTR has completed more than 660 BA/BE studies, 135 pre clinical studies and 9 Clinical Trials in Oncology and 2 in Cosmetology in the span of 6 years of operation. MTR has arrangements with major Hospitals all over India to conduct clinical Trials.

    28. Advantage of selecting mtr State of Art Infrastructure with the updated instruments in Compliance with GLP and GCP norms to complete the project most efficiently and effectively with uncompromised quality . Nationally and Internationally accredited Central Lab Facilities. Rapid turn around time of 45 to 60 days for BA/BE studies with our technical expertise to save the time and cost. Customer Satisfaction Ensures compliance as per requirements of Global regulatory agencies through our exposure & guidance gained by the repeated International Regulatory Audits. Right Volunteer/Patient Pool with multi ethnic background.

    29. Contact us

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