Adgyl Lifesciences

Adgyl Lifesciences Private Limited
Verified

Adgyl Lifesciences offers comprehensive toxicology services for diverse industries - helping innovators bring safer products to market faster. We deliver results to meet high quality & compliance.

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**<br>Adgyl Lifesciences is a GLP-certified laboratory with over three decades of experience in safety and toxicology studies, specializing in supporting drug discovery, preclinical, and early clinical development programs. They are recognized as the first GLP-accredited laboratory in India and have been successfully audited by the USFDA.<br><br>**Expertise &amp; scope**<br>* Comprehensive safety and toxicology studies under GLP and non-GLP compliance.<br>* Specialization in pharmaceuticals, biologics, veterinary pharmaceuticals, nutraceuticals, medical devices, REACH &amp; industrial chemicals, and agrochemicals.<br>* Expertise in Biocompatibility Testing for medical devices, adhering to ISO 10993 standards and FDA guidance.<br>* Services include in vitro ADME, safety assessment, CMC, CDMO, and cGMP synthesis.<br>* Conducts studies for regulatory global registration, IND/NDA packages, and INAD/NADA submissions.<br><br>**Reputation / proof points**<br>* GLP certified since 1992.<br>* AAALAC certified since 2001.<br>* ISO 17025 certified.<br>* Central Drugs Standard Control Organization (CDSCO) registered facility.<br>* Successfully audited by the USFDA in 2012 and 2016.<br>* Over 20 years of experience in conducting Biologics studies.<br>* More than 30 years of experience in Medical Device Testing.<br>* Over 100 completed REACH packages submitted in IUCLID format.

Additional information

Adgyl Lifesciences offers a broad spectrum of services supporting regulatory submissions across various industries. For medical devices, their biocompatibility testing is crucial for 510K submissions and compliance with global regulatory bodies. They also provide comprehensive REACH studies for chemical substances intended for the European Union market. Their services are designed to support clients from the discovery phase through to early clinical development, ensuring safety assessment and regulatory compliance.

Key Highlights

  • Adgyl Lifesciences is the first GLP-accredited laboratory in India.
  • Offers Biocompatibility Testing for medical devices adhering to ISO 10993 standards.
  • Possesses over 30 years of experience in Medical Device Testing.
  • Has completed over 100 REACH packages for submission to the European Chemical Agency (ECHA).

Certifications & Trust Signals

  • GLP certified since 1992.
  • AAALAC certified since 2001.
  • ISO 17025 certified.
  • USFDA audited for GLP studies.

Buyer Snapshot

Best for
  • Companies seeking GLP-compliant safety and toxicology studies.
  • Medical device manufacturers requiring biocompatibility testing.
  • Pharmaceutical and biotech firms navigating drug development.
  • Chemical manufacturers and importers needing REACH compliance.
How engagement typically works
  • Project-based study execution.
  • Collaborative development of testing strategies.
  • Regulatory submission support.
Typical deliverables
  • GLP/non-GLP safety and toxicology study reports.
  • Biocompatibility testing data packages.
  • REACH study reports.
  • CMC and CDMO synthesis reports.
Good to know
  • Best when requiring services compliant with global regulatory standards (GLP, ISO 10993, REACH).
HQ: Bangalore, India
Public email: Abhishek.Chandanan@adgyllifesciences.com
Phone: +91 80 6655 2700
Languages: English
Timezones: Asia/Kolkata
Access: Verified
Claim status: Claimed

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, Hemocompatibility, Carcinogenicity, Genotoxicity
Is Accredited: Yes
Accreditation Body: AAALAC, OECD GLP, ISO 17025 certified and Central Drugs Standard Control Organization (CDSCO) registered facility, ANSI accredited
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)
Lead Time Band: Start in 2-4 weeks
Quote SLA: 24-48 hours
Rush Available: No
Sample Return Policy: Both options
Nda Support: Yes
Minimum Project Size: $50k+

Additional biocompatibility_testing Details

Iso10993 Standards Supported
ISO 10993
Test Types Offered
Biocompatibility Testing, Safety Assessment, Toxicology Studies
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
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