JDM Research has proven capabilities and state-of-the-art infrastructure to provide high quality (OECD GLP), reliable toxicology testing services in the field of product safety assessment to clients throughout the world following OECD, EPA, EU and other test guidelines by a dedicated team of qualified and experienced study directors, senior scientists and toxicologists supported by dedicated veterinarian and animal technicians with special toxicology training, necropsy specialists and pathologists.
A contract research organization (CRO), JDM Research performs a wide range of Preclinical Toxicology studies, including, Mammalian Toxicity, Genetic Toxicology (Mutagenicity), Ecotoxicology, Biocompatibility studies, for pharmaceutical, crop protection / agrochemical, biotechnological, chemical and medical devices industries which wish to obtain national and international registration for their new products, with the respective Governmental regulatory authorities.
State of art double corridor system, comprising 50 animal rooms constructed with a clean room modular wall and ceiling panels and completely Specific pathogen free (SPF) facility with HVAC (350 TR) system to maintain controlled environment as per the national and international guidelines. like CPCSEA and AAALAC/FELASA, for housing and maintaining test systems: Rat, mouse, guinea pig, rabbit, Fish, Birds, Daphnia, Earthworm etc.
Spread over 65,000 square feet. ISO Class 100,000 clean room facility
The norms of use and care of laboratory animals at JDM Research comply with the national and international standards including those prescribed by Committee for the Purpose of Control and Supervision of Experiments on Animals (CPCSEA). The Institutional Biosafety Committee (IBSC),the Institutional Ethics Committee (IEC), the Association for Assessment and Accreditation of Laboratory Animal Care International (AAALAC International), ensure that the laboratory SOPs and the study plans are compliant with ethical and safe practices.
Bio-compatibility testing of medical devices
JDM Research offers full range of bio-compatibility testing as required by the medical device industry in accordance with ISO 10993-1 and FDA guidelines.
| Acute toxicity studies | OECD Guidelines |
|---|---|
| Acute Oral Toxicity (Rat/Mice) | 420, 423, 425 |
| Acute Dermal (Rat) | 402 |
| Acute Inhalation (Rat) | 403 |
| Dermal irritation/ Corrosion (Rabbit) | 404 |
| Eye irritation/ Corrosion Rabbit | 405 |
| Skin Sensitization (Maximization Test and Buehler Test) in Guinea Pig | 406 |
| Repeated dose toxicity studies | OECD Guidelines |
|---|---|
| 28/ 90 / 180 Days Oral | 407, 408, 409 |
| 28/90 Days Inhalation | 412, 413 |
| 28/ 90 / 180 Days Dermal | 410, 411 |
| Chronic / Combine Carci Toxicity Study | 452 / 453 |
| Carcinogenicity Study | 451 |
| Reproduction toxicity studies | OECD Guidelines |
|---|---|
| One Generation Toxicity Study | 415 |
| Reproduction/Developmental Toxicity Screening Test | 421 |
| Combined Repeated Dose Toxicity Study with Reproduction/ Developmental Toxicity Screening Test | 422 |
| Two Generation Toxicity Study | 416 |
| Prenatal Developmental Toxicity Study | 414 |
| Genotoxicity studies (in vitro) | OECD Guidelines |
|---|---|
| Bacterial Reverse Mutation Test (Ames Test) | 471 |
| Micronucleus Test | 473 |
| Mammalian Chromosome Aberration Test | 483 |
| • Using Chinese Hamster Ovary – K1 Cell line | |
| • Using Human Peripheral blood Lymphocytes | |
| Mammalian cell Gene Mutation Test (HPRT assay) | 476 |
| Micronucleus test | |
| • Using Human Lymphocytes from Healthy Donor | 487 |
| • Using Chinese Hamster Ovary (CHO) – K1 cell line |
| Genotoxicity studies (in vivo) | OECD Guidelines |
|---|---|
| Mammalian Erythrocyte Micronucleus Test | 474 |
| In Mice/ Rat (With and without Toxicokinetic) | |
| Mammalian Bone Marrow chromosome Aberration Test In Mice/ Rat (With and without Toxicokinetic) | 475 |
| Mammalian alkaline comet assay | 489 |
| Eco-toxicology studies | OECD Guidelines |
|---|---|
| Acute Oral and Dietary Studies of Chicken/ Pigeon | 205, 206 |
| Acute and Repeated dose toxicity to Fresh water fish | 203 |
| Acute immobilization and reproduction studies on Daphnia magna | 202, 211 |
| Effects on algal growth inhibition | 201 |
| Oral and contact toxicity to honey bees | 213, 214 |
| Acute and Reproduction Toxicity to earthworms | 207, 222 |
| (In vitro) alternate to animal studies | OECD Guidelines |
|---|---|
| Skin Absorption : In Vitro Method | 428 |
| In Vitro Skin corrosion Test - RhE method | 431 |
| Bovine Corneal Opacity & Permeability Assay (BCOP) In vitro test for evaluation of eye irritation based | 437 |
| on opacity and permeability | 492 |
| In Vitro Eye Irritation | 439 |
| In Vitro Skin irritation Test | 442C, 442D |
| In Vitro Skin Sensitization |
| Bio-compatibility testing of medical devices | Guidelines |
|---|---|
| Cytotoxicity | ISO 10993-5 |
| Sensitization | ISO 10993-10 |
| Systemic Toxicity | ISO 10993-11 |
| Genotoxicity | ISO 10993-3 |
| Implantation | ISO 10993-6 |
| Hemocompatibility | ISO 10993-4 |