MTRLMicro Therapeutic Research Labs
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Regulatory-grade data without the operational complexity
More than 1,700 BA/BE studies conducted in strict compliance with international regulatory requirements, monitored by an independent quality assurance department and backed by two decades of experience.
Volunteers : 32,000+
Guidelines : FDA, EMA, ICH, GLP, GCP
FDA EMA ChennaiStudies run to GLP and GCP principles and are documented for FDA, EMA and ICH inspection readiness, drawing on a database of 32,000+ healthy and special-population volunteers.
Terminal
qa@mtrl-chennai study-0427 % mtrl run ba-be protocol.pdf --subjects 24 --periods 2 ✓ Protocol approved by ethics committee ✓ 24 volunteers screened (central lab · NABL) ✓ OVIS check: no cross-participation ✓ Dosing schedule randomized Logs Period 1/2 [] 28% samples=96 lc-ms/ms 00:12 Period 1/2 [] 54% samples=186 lc-ms/ms 00:24 Period 2/2 [] 83% samples=286 lc-ms/ms 00:37 Period 2/2 [] 100% samples=344 lc-ms/ms 00:44 ✓ Report compiled: /reports/ich-e3/csr-v1.pdf
A 22,000 square feet air-conditioned facility in East Tambaram: NABL-accredited central lab, clinical unit, ICU with 24/7 power backup and in-house ambulance, and an LC–MS/MS bioanalytical lab.
Time (h)
LC–MS/MS method development and validation under GLP, OVIS software to prevent cross-participation, ECG data captured to a connected server, and reports prepared to ICH E3.
Quality either exists or does not; it cannot be measured in % terms. Every study is monitored by an independent quality assurance department.
We are answerable for the consequences of our actions, with a robust informed consent process that keeps volunteers safe and informed.
We are accountable for what we say and do, as per our Quality Manual.
Studies run to GLP and GCP principles and reported to ICH E3, with documentation ready for FDA and EMA inspection.
01By the Numbers
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Two decades conducting regulated studies for the pharmaceutical and biotechnology industry.
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Conducted in accordance with international regulatory standards and monitored by an independent quality assurance department.
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Healthy and special populations, including female volunteers, supported by a dedicated mobilization team.
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An air-conditioned clinical unit, ICU, NABL-accredited central lab and LC-MS/MS bioanalytical lab under one roof.
02Our Services
Two-compartment PK model01 / 04
01 · Service
BA/BE Studies conducted at MTRL are in strict compliance with International Regulatory Requirements.
02 · Service
Our Bioanalytical department has been supporting client’s project in the areas of method development validation.
03 · Service
Our team of expert statisticians, SAS programmers, and medical writers have the qualifications, training, and experience necessary to deliver top-notch data analysis services.
04 · Service
Our standard reports are prepared to conform to the requirements of the ICH E3 “Structure and Content of Clinical Study Reports”.
03How a Study Runs
MTRL conducts BA/BE studies in accordance with international regulatory standards, monitored end to end by an independent quality assurance department.
mtrl run ba-be --protocol MTRL-2024 --subjects 24
04Inside MTRL
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Residential facility supporting study subjects through the confinement period.
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LC-MS/MS, UPLC and HPLC instrumentation operated under GLP principles.
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On-site clinical unit with intensive care support for subject safety.
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NABL-accredited bar-coded central lab for study subject screening.
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A 22,000 square feet air-conditioned facility housing the whole operation.
05Our Projects
06Testimonial
“MTRL's quality, responsiveness and customer service with both routine and unique requests are exemplary. Their work shows professionalism with a craftsmanship-like pride that is difficult to find now-a-days.”
“My knowledge in this area is not very strong. I knew what I wanted to achieve but wasn’t sure how to get there. MTRL's got me there and I am ecstatic with the results. Thank you so much.”
“The team members from MTRL's were responsive, hard-working and client oriented. It was easy to work with them and they were always willing to take the time to discuss any concerns and respond to questions.”