About Us

About Us

About Us

MDR Laboratories Pvt. Ltd. offers cost-effective, high-quality biocompatibility solutions in accordance with ISO 10993 for medical devices. We have established a strong reputation as a specialist, mid-sized, independent biocompatibility laboratory, integrating biological evaluation, advanced analytical chemistry with deep toxicological expertise.

Our comprehensive services include biocompatibility testing, chemical characterization, Toxicological Risk Assessment (TRA), and the preparation of Biological Evaluation Plans and Reports (BEP/BER). Our test facility is accredited under Good Laboratory Practice (GLP) and ISO/IEC 17025:2017 standards.

We currently support medical device manufacturers in over 55 countries, and our reports are widely accepted by the U.S. FDA, EU Notified Bodies, and other global regulatory authorities.

In 2025, MDR was acquired by MDR Laboratories-a move that reflects our commitment to the medical device sector. This strategic partnership marks the beginning of an exciting new chapter, aligned with MDR’s vision of growth, innovation, and global excellence.

Infrastructure

Map
Facility and Resources

Facility and Resources

  • 20,000 ft2 custom designed compact laboratory work space
  • CCSEA approved in vivo laboratory with 30 animal rooms
  • Surgical theatre for implantation studies
  • In vitro laboratory with several cell culture facilities
  • Genetic Toxicology laboratory
  • Pathology, Hematology and Clinical Biochemistry laboratories
  • Separate unit for extract preparation, a key step in biocompatibility assessment
  • Analytical chemistry instrumentation (GC-MS, LC-MS, ICP-OES, FTIR and others)
  • Dedicated Test Item Control and Archival facilities are available
  • The test facility is OECD GLP and ISO 17025:2017 accredited and has a separate Quality Assurance unit
Scientific Team

Scientific Team

Our staff have a sound Scientific and Regulatory background and are professionals from the following fields:

  • American board certified as well as UK/EU registered Toxicologists
  • Medical professionals
  • Veterinarians
  • Pharmacologists
  • Pathologists
  • Biomedical engineers
  • Biotechnologists
  • Biochemists
  • Regulatory professionals
  • IT professionals

Leadership Team

Why MDR?

MDR offers pioneering support for all your outsourced toxicology needs backed by the highest scientific and service commitment.
MDR is headed by senior toxicologists, who have extensive experience, working in various International and Indian CROs, and with a wide range of clients. At MDR, we always ensure comfort of our clients through the period of the study and thereafter.

High Quality Standards

High Quality Standards

At MDR, we strongly believe that all clients require high quality results that they can confidently depend on for their regulatory or product development needs. To ensure this MDR has implemented a Quality Assurance System that will fulfill all GLP and ISO 17025 requirements, as well as industry-tested good practices from other GxPs.

Cost Effectiveness

Cost Effectiveness

As a small CRO and located in India, MDR is in a position to offers cost effective solutions without compromising the quality or scientific integrity of the studies.

Network of Laboratories and Consultants

Network of Laboratories and Consultants

MDR has an extensive network of working partners in terms of various laboratories/consultants in India and abroad. This enables us to position ourselves as a One-Stop-Shop for Toxicology, by offering practically the widest range of toxicology or pharmacology studies for our clients.

Regulatory and Scientific Consultations

Regulatory and Scientific Consultations

Scientific consultations are our major strength, which most of the other Asian CROs do not offer. Our experts have proven experience in moving lead candidates to IND and subsequent market approval. They can suggest you suitable research options enabling a quick turn-around of studies for regulatory submissions. To support our scientific needs we have an extensive network of academic and industrial scientists who work with us on a part-time basis.