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, offering a comprehensive suite of safety and toxicology studies for drug discovery, preclinical, and early clinical development programs. They specialize in supporting regulatory global registration across various industries.

**Expertise & scope**
* Pharmaceuticals and Biologics (small molecules and biologics)
* Veterinary Pharmaceuticals (including vaccines and biologics)
* Nutraceuticals and food ingredients
* Medical Devices (Biocompatibility testing)
* REACH & Industrial Chemicals
* Agrochemicals and Cosmetics
* Services include in vitro and in vivo pharmacology, safety assessment, CMC, CDMO, and bioanalysis.
* Expertise in GLP and non-GLP studies, with specific experience in vaccine safety studies, monoclonal antibodies, ADCs, peptides, and gene therapy products.
* Support for regulatory submissions such as IND/NDA packages, Investigational New Animal Drug (INAD), New Animal Drug Application (NADA), and 510K submissions.

**Reputation / proof points**
* GLP-accredited laboratory in India.
* Audited by the USFDA for GLP studies (2012 and 2016).
* AAALAC-accredited animal facility.
* ISO 17025 certified and Central Drugs Standard Control Organization (CDSCO) registered facility.
* GLP certified since 1992, AAALAC certified since 2001.
* Over 30 years of toxicology and safety experience.
* Experience in conducting over 20,000 GLP studies.
* Completed over 100 REACH packages submitted in IUCLID format.

Additional information

Adgyl Lifesciences provides specialized biocompatibility testing for medical devices, adhering to the latest ISO 10993 standards and FDA guidance. Their team possesses extensive experience in biological safety assessment and toxicological evaluation, ensuring worldwide acceptability of GLP-compliant data. For pharmaceutical and biotech clients, they offer services ranging from early-stage drug discovery through preclinical and early clinical development, including both non-GLP and regulatory GLP-compliant studies. Their capabilities extend to the synthesis of small molecules and GMP CDMO services for clinical APIs, supporting the development of pharmaceuticals, biologics, and veterinary products.

Key Highlights

  • GLP certified since 1992, AAALAC certified since 2001, and ISO 17025 certified. 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.”
  • USFDA audited for GLP studies submitted as part of IND / NDA packages. 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.”
  • Specializes in Biologics including monoclonal antibodies, ADCs, peptides, vaccines, and gene therapy products. Source
    “The Test facility has more than 20- years of experience in conducting Biologics studies for Novel biologics, Biosimilar monoclonal antibodies & Fc fusion proteins, ADCs, Peptides, Vaccines and Gene therapy products”
  • Offers comprehensive Biocompatibility testing for medical devices as per ISO 10993 standards. Source
    “can help develop -an appropriate testing program for assessing the safety of – Medical Devices as per the latest ISO 10993 standards”
  • Completed over 100 REACH packages for the European Chemical Agency (ECHA). Source
    “Adgyl has completed more than 100 REACH packages and submitted to Agency in the International Uniform Chemical Information Database (IUCLID) format.”

Certifications & Trust Signals

  • GLP certified since 1992. Source
    “The Test Facility, Adgyl Lifesciences, is GLP certified since 1992”
  • AAALAC certified since 2001. Source
    “AAALAC certified since 2001”
  • ISO 17025 certified. Source
    “is an ISO 17025 certified”
  • USFDA audited. Source
    “has been successfully audited by the USFDA (2012 and 2016)”

Buyer Snapshot

Best for
  • Companies seeking GLP-compliant safety and toxicology studies.
  • Medical device manufacturers requiring biocompatibility testing.
  • Pharmaceutical and biotech firms in preclinical and early clinical development.
How engagement typically works
  • Project-based study design and execution.
  • Collaborative approach to regulatory submissions.
Typical deliverables
  • GLP safety and toxicology study reports.
  • Biocompatibility testing data for medical devices.
  • CMC and CDMO services for clinical APIs.
  • REACH study reports.
Good to know
  • Best when requiring GLP-certified studies for regulatory submissions.
  • Best when needing specialized testing for medical devices, biologics, or veterinary pharmaceuticals.
HQ: Bangalore, India
Languages: English
Timezones: Asia/Kolkata
Status: listed

Services & Capabilities

Biocompatibility Testing (ISO 10993 Program)

Countries: United States, Germany, Netherlands, India, Europe
Industries: Medical Devices
Iso10993 Standards Supported: ISO 10993-1, ISO 10993-5, ISO 10993-10, ISO 10993-11, ISO 10993-12, ISO 10993-18
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, Development & Reproductive Toxicity, Vaccine safety studies, Biologics studies, Veterinary Pharmaceuticals safety studies.
Contact Types Supported: Surface contact, External communicating, Implant
Duration Types Supported: Limited (< 24h), Prolonged (24h - 30d), Permanent (> 30d)
Nda Support: Yes

Additional biocompatibility_testing Details

Iso10993 Standards Supported
ISO 10993
Test Types Offered
Biocompatibility Testing, Safety and Toxicology Studies, Pharmacology Studies, ADME Studies, CMC Synthesis, CDMO Services, Bioanalysis
Contact Types Supported
N/A
Duration Types Supported
N/A
Lead Time Band
Start in 2-4 weeks
Quote SLA
24-48 hours
Sample Return Policy
N/A
Minimum Project Size
$50k+
Pricing Model
Per project
Request quotes
Cruxi - Regulatory Compliance Services