Adgyl Lifesciences
Adgyl Lifesciences Private Limited
Adgyl Lifesciences offers comprehensive GLP and non-GLP safety and toxicology studies for drug discovery and development. They specialize in pharmaceuticals, biologics, veterinary pharmaceuticals, and medical devices.
Adgyl Lifesciences is a leading Contract Research Organization (CRO) and Contract Development and Manufacturing Organization (CDMO) in India, offering a wide spectrum of services for drug discovery, preclinical, and early clinical development programs. They are recognized for their state-of-the-art infrastructure and a highly experienced team dedicated to advancing research and development. Their expertise spans various therapeutic areas including Pharmaceuticals & Biotech, Biologics, Veterinary Pharmaceuticals, Nutraceuticals, and Medical Devices. Adgyl Lifesciences provides comprehensive GLP and non-GLP safety and toxicology studies, essential for regulatory registration and global market submissions. They are particularly noted for being the first GLP-accredited laboratory in India and have successfully undergone audits by the USFDA. Adgyl Lifesciences supports the development of small molecules and biologics, offering services such as medicinal chemistry, in vitro biology, in vivo pharmacology, safety assessment, and CMC. They also provide non-GMP and cGMP synthesis services for clinical development. Their commitment to quality and regulatory compliance ensures reliable data generation for clients worldwide.
About
**Who they are**
Adgyl Lifesciences is a GLP-certified laboratory based in India, with a history of USFDA audits and AAALAC accreditation since 2001. They specialize in safety and toxicology studies for various industries, including pharmaceuticals, biologics, veterinary pharmaceuticals, and medical devices.
**Expertise & scope**
* Offers comprehensive GLP and non-GLP safety and toxicology studies for drug discovery and development.
* Specializes in pharmaceuticals, biologics (including monoclonal antibodies, ADCs, peptides, vaccines, and gene therapy products), veterinary pharmaceuticals, nutraceuticals, medical devices, REACH & Industrial Chemicals, agrochemicals, and cosmetics.
* Provides Biocompatibility testing for medical devices, adhering to ISO 10993 standards and FDA guidance.
* Conducts studies for regulatory submissions such as IND/NDA packages, 510K submissions, and New Animal Drug Applications.
* Expertise in medicinal chemistry, in vitro biology, in vivo pharmacology, in vitro ADME, safety assessment, CMC, and CDMO services.
* Offers non-GMP and cGMP synthesis services for early and late clinical development.
**Reputation / proof points**
* First GLP-accredited laboratory in India.
* Successfully audited by the USFDA in 2012 and 2016 for GLP studies.
* AAALAC accredited since 2001.
* ISO 17025 certified and Central Drugs Standard Control Organization (CDSCO) registered facility.
* Over 30 years of toxicology and safety experience.
* Medical Device Testing team with 30 years of GLP testing experience and 100+ years of accumulated experience in biological safety assessment.
Adgyl Lifesciences is a GLP-certified laboratory based in India, with a history of USFDA audits and AAALAC accreditation since 2001. They specialize in safety and toxicology studies for various industries, including pharmaceuticals, biologics, veterinary pharmaceuticals, and medical devices.
**Expertise & scope**
* Offers comprehensive GLP and non-GLP safety and toxicology studies for drug discovery and development.
* Specializes in pharmaceuticals, biologics (including monoclonal antibodies, ADCs, peptides, vaccines, and gene therapy products), veterinary pharmaceuticals, nutraceuticals, medical devices, REACH & Industrial Chemicals, agrochemicals, and cosmetics.
* Provides Biocompatibility testing for medical devices, adhering to ISO 10993 standards and FDA guidance.
* Conducts studies for regulatory submissions such as IND/NDA packages, 510K submissions, and New Animal Drug Applications.
* Expertise in medicinal chemistry, in vitro biology, in vivo pharmacology, in vitro ADME, safety assessment, CMC, and CDMO services.
* Offers non-GMP and cGMP synthesis services for early and late clinical development.
**Reputation / proof points**
* First GLP-accredited laboratory in India.
* Successfully audited by the USFDA in 2012 and 2016 for GLP studies.
* AAALAC accredited since 2001.
* ISO 17025 certified and Central Drugs Standard Control Organization (CDSCO) registered facility.
* Over 30 years of toxicology and safety experience.
* Medical Device Testing team with 30 years of GLP testing experience and 100+ years of accumulated experience in biological safety assessment.
Additional information
Adgyl Lifesciences supports a wide range of research phases, from discovery and preclinical to early clinical development, focusing on safety assessment and regulatory global registration. Their services are designed to meet requirements for various regulatory bodies, including the USFDA, ECHA, and WHO protocols. For medical device biocompatibility, they develop testing programs aligned with the latest ISO 10993 standards and FDA guidance, ensuring worldwide acceptability through GLP compliance. They also have experience in designing REACH studies as per European Chemical Agency (ECHA) requirements, having completed over 100 REACH packages.
Key Highlights
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Adgyl Lifesciences is the first GLP-accredited laboratory in India and has been successfully audited by the USFDA.
Source
“Adgyl Lifesciences is the first GLP-accredited laboratory in India and has been successfully audited by the USFDA (2012 and 2016) for GLP studies submitted as part of IND / NDA packages.”
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They offer Biocompatibility testing for medical devices, adhering to ISO 10993 standards and FDA guidance.
Source
“The Test Facility, Adgyl Lifesciences, is GLP certified since 1992, AAALAC certified since 2001, and is an ISO 17025 certified and Central Drugs Standard Control Organization (CDSCO) registered facility.”
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The company has over 30 years of toxicology and safety experience.
Source
“Leveraging on its Toxicology and Safety experience and credibility of over three decades, Adgyl Lifesciences is your ideal partner to provide Biocompatibility testing services toward the development of your Medical Device programs”
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Adgyl Lifesciences has experience in designing REACH studies as per European Chemical Agency (ECHA) requirements.
Source
“Adgyl Lifesciences has experience and expertise in designing the REACH studies as per European Chemical Agency (ECHA) requirements.”
Certifications & Trust Signals
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GLP certified since 1992.
Source
“The Test Facility, Adgyl Lifesciences, is GLP certified since 1992”
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AAALAC certified since 2001.
Source
“AAALAC certified since 2001”
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ISO 17025 certified.
Source
“and is an ISO 17025 certified and Central Drugs Standard Control Organization (CDSCO) registered facility.”
Buyer Snapshot
Best for
- Companies developing pharmaceuticals, biologics, veterinary drugs, or medical devices requiring GLP safety and toxicology studies.
- Organizations needing biocompatibility testing for medical devices according to ISO 10993 standards.
- Businesses seeking regulatory support for submissions to agencies like the USFDA and ECHA.
How engagement typically works
- Collaborative study design and execution.
- Focus on regulatory compliance and data integrity.
- Leveraging extensive experience for efficient development programs.
Typical deliverables
- GLP and non-GLP safety and toxicology study reports.
- Biocompatibility testing data for medical devices.
- CMC and CDMO synthesis reports.
- REACH study documentation.
Good to know
- Best when requiring GLP-compliant studies for regulatory submissions.
- Best when needing specialized testing for complex biologics or medical devices.
HQ:
Bangalore, India
Languages:
English
Timezones:
Asia/Kolkata
Claim status:
Listed
Services & Capabilities
Biocompatibility Testing (ISO 10993 Program)
Countries:
United States, Germany, Netherlands, India, Europe
Industries:
Medical Devices
Pricing model:
Per project
Iso10993 Standards Supported:
ISO 10993-1, ISO 10993-5, ISO 10993-10, ISO 10993-11
Test Types Offered:
Cytotoxicity, Sensitization, Irritation, Systemic toxicity, Reproductive toxicity, Pharmacokinetics, Other
Is Accredited:
Yes
Accreditation Body:
USFDA
Glp Compliant:
Yes
Has In House Toxicology:
Yes
Toxicology Capabilities:
Comprehensive Range of Pharmacology & GLP Safety Assessment Services, Toxicology Studies, GLP toxicology studies, Orally (gavage, capsule, fortified diet, drinking water), Parenteral (intravenous bolus and infusion, intramuscular, subcutaneous), ocular, intranasal, inhalation etc., DEVELOPMENT & REPRODUCTIVE TOXICITY, (MTD/DRF/14/28/90/180 day) Study in Rodents & Non-Rodents, Vaccine safety studies, Biologics safety/Toxicology studies
Contact Types Supported:
Surface contact, External communicating, Implant
Duration Types Supported:
Limited (< 24h), Prolonged (24h - 30d), Permanent (> 30d)
Nda Support:
Yes
Lead Time Band:
Start in 2-4 weeks
Quote SLA:
24-48 hours
Minimum Project Size:
$50k+
Sample Return Policy:
Dispose
Additional biocompatibility_testing Details
Iso10993 Standards Supported
ISO 10993
Test Types Offered
Safety assessment, Toxicology studies, Biocompatibility testing, Medicinal Chemistry, in vitro Biology, in vivo Pharmacology, in vitro ADME, CMC, CDMO synthesis, Bioanalysis of Clinical Samples
Contact Types Supported
Surface contact, External communicating, Implant
Duration Types Supported
Limited (< 24h), Prolonged (24h - 30d), Permanent (> 30d)
Lead Time Band
Start in 0-2 weeks
Quote SLA
< 24 hours
Sample Return Policy
Dispose
Minimum Project Size
$25-50k
Pricing Model
Per project
