Comprehensive Pre-Clinical &
Testing Services
OECD GLP accredited testing laboratory delivering regulatory toxicology, biocompatibility evaluation, analytical chemistry, and microbiological testing across pharmaceuticals, medical devices, agrochemicals, and herbal products.
Medical Device Testing
ISO 10993 Biocompatibility & Safety Evaluation
Comprehensive biological evaluation of medical devices to assess biocompatibility, cellular response, and systemic safety per ISO 10993 and global regulatory standards.
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In Vitro Studies
Cell-culture assays evaluating cytotoxicity, in vitro hemolysis, irritation, and genetic toxicity without animal testing.
In Vivo Studies
Targeted animal evaluation to verify systemic tolerance, tissue compatibility, implantation safety, and sensitization.
Analytical Testing
High-Resolution Chromatography & Impurity Profiling
Advanced method development, validation, elemental impurities, nitrosamines, stability, and 5-batch analysis per ICH, USP, and OECD GLP guidelines.
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Pharmaceutical Testing
Method development, verification/validation, nitrosamine screening, extractables/leachables, and stability studies.
Medical Device Testing
Chemical characterization of materials, identification of extractables and leachables, and toxicological risk estimation.
Agrochemical Testing
5-batch active ingredient profiling, impurity screening, and physical-chemical parameter determination per CIPAC and EPA.
Cosmetic, Ayush & Herbal Testing
Safety, quality, heavy metal screening, pesticide residue evaluation, and herbal marker profiling for AYUSH and cosmetics.
Other Services
Tailored analytical protocols, specialized characterization, particle sizing, and specialized non-routine laboratory studies.
Microbiological Testing
Sterility, Microbial Quality & Environmental Safety
Full-spectrum cGMP microbiological evaluation, cleanroom monitoring, utility validation, and disinfectant qualification for healthcare products.
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Sterility & Microbial Quality Studies
Sterility verification per USP <71>, bioburden determination on medical devices, and microbial limit testing (MLT).
Method Validation / Verification
Microbial recovery verification, method suitability, and validation ensuring absence of antimicrobial inhibition.
Sterilization & Aseptic Processing
Biological indicator qualification, autoclave and EO sterilization cycle verification, and aseptic process simulation.
Environmental Monitoring
Viable and non-viable particle monitoring, surface swabbing, and settle plate monitoring for ISO cleanrooms and isolators.
Pharmaceutical Water & Utility Studies
Comprehensive microbiological and physico-chemical evaluation of Purified Water, Water for Injection (WFI), and clean utilities.
Cleaning & Disinfection Studies
Disinfectant efficacy validation (surface coupon challenge) against standard and environmental isolate organisms.
Agrochemical Microbiology Service
Microbial contamination screening, viable count determination, and shelf-life verification for agrochemical formulations.
Pharmacology & Toxicology Testing
OECD GLP Regulatory Safety Assessment
Comprehensive regulatory toxicology, safety pharmacology, in vitro genetic assays, and advanced immunology supporting IND/NDA filings.
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In - Vitro Toxicology
Bacterial reverse mutation (Ames test), mammalian chromosomal aberration, and in vitro micronucleus assays per OECD guidelines.
Molecular Biology & Immunological Assays
ELISA quantification, flow cytometry, gene expression profiling, and immunogenicity evaluation for biologics and new chemical entities.
In - Vivo Toxicology
Acute, sub-acute (28 days), sub-chronic (90 days), and chronic systemic toxicity studies conducted in our state-of-the-art animal facility.
Pre-Clinical Scope & Capabilities
We Perform Below Mentioned Studies in RRC:
Ribosome Research Centre delivers comprehensive biocompatibility evaluation, toxicological risk assessment, and specialized testing in compliance with OECD GLP, ISO, and global regulatory standards.
Our Process
Our Approach To Accurate &
Compliant Testing
Build your career in a research environment that values scientific curiosity, quality and teamwork. At Ribosome Research Centre, people
contribute to work that supports the understanding of products and the evidence behind development decisions.
Requirement Understanding
We begin by understanding your product, testing requirements, and regulatory objectives to define a clear analytical strategy.
Method Development & Planning
Our team develops and optimizes analytical methods, ensuring alignment with ICH, USP, and global regulatory standards.
Testing & Analysis
Samples are tested using advanced instrumentation such as LC-MS/MS, ICP-MS, and other validated techniques for accurate results.
Reporting & Compliance Support
We deliver detailed, audit-ready reports and provide support for regulatory submissions and compliance requirements.
Partner With Ribosome Research Centre
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