Advinus
Eurofins Advinus
★★★★★
4.4
/ 5
•
50 reviews
Eurofins Advinus is a contract research organization (CRO) specializing in biocompatibility testing and preclinical drug development services. They offer expertise in ADMET, CDMO services, and IND-enabling studies.
Eurofins Advinus is a leading Contract Research Organization (CRO) providing comprehensive services for drug discovery and development. They specialize in biocompatibility testing, ADMET studies, CDMO services including process research and development, analytical development, process safety, and manufacturing. Their expertise extends to preclinical drug development and IND-enabling studies, with a proven track record of supporting successful IND submissions to the US FDA. The company emphasizes quality, flexibility, and adherence to timelines, making them a valuable partner for biotech companies. Clients highlight their proactive approach, scientific competence, and professionalism in navigating complex regulatory requirements. Eurofins Advinus is committed to delivering high-quality reports and data packages essential for early-stage development and regulatory submissions.
About
**Who they are**
Eurofins Advinus is a contract research organization (CRO) specializing in preclinical drug development and biocompatibility testing services. They offer expertise in ADMET, CDMO services, and IND-enabling studies.
**Expertise & scope**
* GLP-compliant toxicology services for regulatory registration of crop protection agents and industrial chemicals, in collaboration with partner laboratory Adgyl Lifesciences.
* Comprehensive toxicology required for agrochemical product approval, with over 7,000 GLP studies conducted by Adgyl Lifesciences.
* Chemical characterization for medical devices, including extractables studies for container closure systems.
* Generation and analysis of extracts from packaging materials using accelerated techniques.
* Quantitative/qualitative analysis of generated extracts with highly sensitive equipment for low LOQs.
* Integrated discovery chemistry services for drug development, from hit identification to IND-enabling studies.
* Support for early drug development stages including synthetic, medicinal, computational, and analytical chemistry.
* Preclinical drug development and IND-enabling studies, including process optimization, ADME, formulation development, toxicology, and toxicokinetics.
**Reputation / proof points**
* Accredited by BfR, AAALAC International, USFDA, CCSEA, and Indian GLP authorities via partner laboratory Adgyl Lifesciences.
* Expertise in meeting regulatory requirements for agencies such as US EPA, EMA, MHRA, REACH, and CIB (India).
Eurofins Advinus is a contract research organization (CRO) specializing in preclinical drug development and biocompatibility testing services. They offer expertise in ADMET, CDMO services, and IND-enabling studies.
**Expertise & scope**
* GLP-compliant toxicology services for regulatory registration of crop protection agents and industrial chemicals, in collaboration with partner laboratory Adgyl Lifesciences.
* Comprehensive toxicology required for agrochemical product approval, with over 7,000 GLP studies conducted by Adgyl Lifesciences.
* Chemical characterization for medical devices, including extractables studies for container closure systems.
* Generation and analysis of extracts from packaging materials using accelerated techniques.
* Quantitative/qualitative analysis of generated extracts with highly sensitive equipment for low LOQs.
* Integrated discovery chemistry services for drug development, from hit identification to IND-enabling studies.
* Support for early drug development stages including synthetic, medicinal, computational, and analytical chemistry.
* Preclinical drug development and IND-enabling studies, including process optimization, ADME, formulation development, toxicology, and toxicokinetics.
**Reputation / proof points**
* Accredited by BfR, AAALAC International, USFDA, CCSEA, and Indian GLP authorities via partner laboratory Adgyl Lifesciences.
* Expertise in meeting regulatory requirements for agencies such as US EPA, EMA, MHRA, REACH, and CIB (India).
Additional information
Eurofins Advinus provides comprehensive services for medical device biocompatibility testing, including chemical characterization. They utilize state-of-the-art instrumentation for generating and analyzing extracts from packaging materials, mimicking final product conditions. Their approach involves accelerated extraction techniques and sensitive analytical methods to achieve low limits of quantification (LOQs). For agrochemical development, they offer GLP-compliant toxicology services through a trusted partner, covering a wide range of studies necessary for regulatory registration. Their drug discovery services integrate chemistry and biological profiling for efficient development cycles.
Key Highlights
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Offers GLP-compliant toxicology services for agrochemical and industrial chemical registration.
Source
“Eurofins Advinus, in collaboration with its trusted partner laboratory Adgyl Lifesciences, offers comprehensive GLP-compliant toxicology services to support the regulatory registration of crop protection agents and industrial chemicals.”
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Provides chemical characterization and extractables studies for medical device container closure systems.
Source
“Eurofins Advinus is offering extractables studies for container closure systems.”
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Expertise in preclinical drug development and IND-enabling studies, contributing to FDA submissions.
Source
“I commend Eurofins Advinus team for their highest quality of work and professionalism, understanding of regulatory requirements, and drive to resolve complexities during the TT-4 and TT-10 programs on early development, Chemistry Manufacturing and Controls (CMC) and preclinical IND programs...”
Certifications & Trust Signals
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Testing facility operated via partner Adgyl Lifesciences is accredited by BfR, AAALAC International, USFDA, CCSEA, and Indian GLP authorities.
Source
“The testing facility operated via Adgyl Lifesciences is accredited by BfR, AAALAC International, USFDA, CCSEA, and Indian GLP authorities, ensuring adherence to the highest global standards.”
Buyer Snapshot
Best for
- Companies seeking GLP-compliant toxicology and preclinical drug development services.
- Agrochemical, chemical, and pharmaceutical industries requiring regulatory submission support.
- Organizations needing specialized ADMET and discovery chemistry expertise.
How engagement typically works
- Full-Time Equivalent (FTE)
- Fee-For-Service (FFS)
Typical deliverables
- GLP toxicology study reports
- ADMET study data
- Discovery chemistry synthesis and optimization
- API process development packages
- IND-enabling study support
Good to know
- Best when requiring services with strong GLP compliance and international regulatory acceptance.
Pricing
Model:
Custom pricing
HQ:
Bangalore, India
Languages:
English
Timezones:
UTC+5:30
Claim status:
Listed
Services & Capabilities
Biocompatibility Testing (ISO 10993 Program)
Countries:
United States, India, Asia
Industries:
Medical Devices
Pricing model:
Custom pricing
Iso10993 Standards Supported:
ISO 10993-1, ISO 10993-5, ISO 10993-10, ISO 10993-11
Test Types Offered:
Cytotoxicity, Sensitization, Irritation, Systemic toxicity, Genotoxicity, Carcinogenicity, Reproductive toxicity, Pharmacokinetics
Is Accredited:
Yes
Glp Compliant:
Yes
Has In House Toxicology:
Yes
Toxicology Capabilities:
Capabilities for full range of toxicology studies required by agrochemicals, chemicals (REACH), dyes, and other such industries. Conducted more than 7000 GLP studies for submissions to regulatory authorities globally. Routine chronic toxicity, reproduction toxicity, juvenile toxicity and carcinogenicity studies. Performed 6 month carcinogenicity study in Tg RasH2 transgenic mouse model. Experienced team with 35 highly qualified study directors and 9 Diplomates of the American Board of Toxicology (DABT) certified toxicologists.
Contact Types Supported:
External communicating, Implant
Duration Types Supported:
Limited (< 24h), Prolonged (24h - 30d), Permanent (> 30d)
Rush Available:
Yes
Nda Support:
Yes
Accreditation Body:
BfR German Health Ministry, W&V Netherlands, Indian GLP authorities, AAALAC International, USFDA
Sample Requirements:
Extraction medium will mimic the final product.
Regions Served:
Global
Additional biocompatibility_testing Details
Iso10993 Standards Supported
ISO 10993
Test Types Offered
Biocompatibility Testing, Toxicology Studies (Agrochemicals, Chemicals, Dyes), ADMET Studies, Discovery Chemistry, API Process Research and Development
Pricing Model
Fee-For-Service (FFS), Full-Time Equivalent (FTE)
