MTRLMicro Therapeutic Research Labs
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01Bio - Analytical Services
Our dedicated and knowledgeable scientists are well-trained in GLP and GCP regulations, ensuring the highest quality data. All procedures comply with applicable regulatory guidelines including USFDA, WHO, ANVISA, NPRA, and EMA.
The team utilizes state-of-the-art instruments, such as LC-MS/MS, UPLC, HPLC, ICP-MS, and Ion-Chromatography, to complete projects with uncompromising data integrity.
Method development, validation, sample analysis, reporting and submission
230+ validated methods, including assays as low as 1 pg/mL, with approximately 2–3 new methods validated every month, for proprietary (NCE) and non-proprietary assays.
LC-MS/MS, UPLC, HPLC, ICP-MS and Ion-Chromatography complete projects with uncompromising data integrity, backed by controlled sample storage from −20°C to −80°C.
From chiral and conjugated small molecules to mAbs and biosimilars, plus BCS bio-waiver permeability assays and phosphate binding studies.
All procedures comply with applicable regulatory guidelines including USFDA, WHO, ANVISA, NPRA and EMA.
02Core Bioanalytical Services
State-of-the-art Liquid Chromatography–Mass Spectrometry (LC-MS/MS) for accurate, sensitive quantification of drugs and metabolites in biological matrices (plasma, urine, tissue samples). This advanced technology ensures the highest level of data precision for small molecules and biologics.
Specialized testing for biosimilars, ensuring that these biologic products are highly similar to their reference biologics in terms of pharmacokinetics (PK), efficacy, and immunogenicity. Our bioanalytical services comply with FDA, EMA, and ICH guidelines for biosimilar approval.
Advanced testing for large molecules (e.g., monoclonal antibodies, therapeutic proteins, peptides) using techniques like LC-MS/MS and ELISA. These services support the development of biologics and help assess pharmacokinetics, immunogenicity, and drug concentrations in biological matrices.
Custom development and validation of bioanalytical methods for small and large molecules, ensuring they meet stringent regulatory guidelines (FDA, EMA, ICH). We provide reliable, reproducible, and accurate results.
In-depth analysis of drug absorption, distribution, metabolism, and excretion (ADME) to support clinical trials, bioequivalence studies, and regulatory submissions. These studies provide essential data for dose optimization and drug efficacy.
Comprehensive toxicokinetic studies to assess the safety of investigational drugs. This includes dose escalation studies, toxicity testing, and determining safe dose ranges for clinical trials.
Detection and characterization of immune responses to biologics and therapeutic proteins. This ensures that biologics and biosimilars do not provoke adverse immune reactions, crucial for the safety profile of your products.
Secure, long-term storage of clinical samples in compliance with regulatory standards. We ensure proper traceability, integrity, and preservation of all biological samples throughout the trial lifecycle.
03Specialized Capabilities
04Infrastructure
| Instruments Specification | No. of Instruments |
|---|---|
| LC-MS/MS (Waters Xevo TQMS, Quattro Micro Mass, API 5500, 4000 & 3200) | 19 |
| ICPMS | 1 |
| GC-MS/HS | 1 |
| HPLC | 2 |
| Deep Freezers (-20°C) | 2 |
| Deep Freezers (-30°C) | 5 |
| Deep Freezer (-40°C) | 3 |
| Deep Freezers (-80°C) | 9 |
05Operational Capabilities
Explore
Bioequivalence Studies
Learn more →02Precision Testing for Topical Preparations
Learn more →03Expert Medical Writing in Clinical Research
Learn more →04Accurate and Reliable Clinical Data Management
Learn more →05Ensuring Regulatory Compliance with Independent Audits
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