Registration, Evaluation, Authorisation, and Restriction of Chemicals (REACH) Support
Supporting chemical safety and environmental protection through robust REACH compliant solutions.
Industry Focus
Enabling safe use of chemical substances through comprehensive regulatory strategy and International Uniform Chemical Information Database (IUCLID) dossier submissions.
In the chemical industry, compliance with the REACH regulations is crucial. REACH addresses the production and use of chemical substances, and their potential impacts on both human health and the environment.
Adgyl Lifesciences actively supports and facilitates adherence to REACH requirements, supporting REACH studies from 1–100 tonnes or more, and enhancing the chemical industry’s commitment to safety and compliance. We have completed more than 100 REACH packages and submitted them to regulatory agencies in IUCLID format.
Core capabilities
- Annex VII (1 Tonne or More)
- Bacterial Reverse Mutation Test (Ames Test) (OECD 471)
- Acute Oral Toxicity Study in Rats (OECD 420/423/425)
- Acute Dermal Irritation/Corrosion Study in Rabbits (OECD 404)
- Acute Eye Irritation/Corrosion Study in Rabbits (OECD 405)
- Skin Sensitization Study in Guinea Pigs (OECD 406) or
- Local Lymph Node Assay (LLNA) in CBA/Ca mice (OECD 429)
- Annex IX (100 Tonnes or More)
In addition to the tests performed under Annex VIII (10 Tonnes or More), other tests include:
- Mammalian Erythrocyte Micronucleus Test (OECD 474)
- Mammalian Bone Marrow Chromosomal Aberration Test (OECD 475)
- 90-Day Repeated Dose (OECD 408)
- Extended One-Generation Reproduction Toxicity Study in Rats (OECD 443)
- Annex VIII (10 Tonnes or More)
- Bacterial Reverse Mutation Test (Ames Test) (OECD 471)
- In Vitro Mammalian Chromosomal Aberration Test (CHO cells) (OECD 473)
- In Vitro Mammalian Cell Gene Mutation Test Using the Hprt and xprt genes (OECD 476)
- In Vitro Mammalian Cell Micronucleus Test (Human Peripheral Blood Lymphocytes-HPBL) (OECD 487)
- Acute Oral Toxicity Study in Rats (OECD 420/423/425)
- Acute Dermal Toxicity Study in Rats (OECD 402)
- Acute Inhalation Study in Rats (OECD 403)
- Acute Dermal Irritation/Corrosion Study in Rabbits (OECD 404)
- Acute Eye Irritation/Corrosion Study in Rabbits (OECD 405)
- Skin Sensitization Study in Guinea Pigs (OECD 406) or
- Local Lymph Node Assay (LLNA) in CBA/Ca mice (OECD 429)
- 28-Day Repeated Dose (OECD 407)
- Reproductive Toxicity (OECD 421/422)
- Pre-natal Developmental Toxicity study (OECD 414)
- Annex X (1000 Tonnes or More)
In addition to the tests performed under Annex IX (100 tonnes or more), another test includes:
- Chronic Toxicity (OECD 452)/ Carcinogenicity (Oncogenicity) (OECD 451)
Regulatory Credentials
Regulatory & Quality Credentials
- First GLP-Accredited in India
We are 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.
- Certified Quality Standards
Our vivarium was the first to have been accredited by the Association for Assessment and Accreditation of Laboratory Animal Care International (AAALAC) since 2001 and all animal study protocols are reviewed and approved by the Institutional Animal Ethics Committee (IAEC), which is equivalent to Institutional Animal Care and Use Committee (IACUC).
Proven Experience
Established Expertise
With over 1100 clients and 30+ years of experience in conducting drug development studies. We are proud of our strong track record of regulatory submissions and robust historical control data and therefore feels confident in developing and thoroughly assessing the safety profile of your molecules. As an extension of your team, our scientists and technicians will help enable and expedite your research goals, ensuring that your preclinical drug development program provides quality data for key decision-making.
Global Clients
Years Experience
Global Regulatory Submissions
Investigational New Drug
(IND) packages submitted
- USFDA (US)
- EMA (Europe)
- MHRA (UK)
Global Regulatory Submissions
Investigational New Drug (IND) packages submitted
- EMA (Europe)
- MHRA (UK)
- USFDA (US)
what people ask
Frequently Asked Questions
What REACH services do you offer?
We provide comprehensive REACH compliance support, including study execution and IUCLID dossier submissions.
What tonnage bands do you support under REACH?
We support studies across all tonnage bands from 1 tonne to 1000+ tonnes.
Do you support both in vitro and in vivo studies?
Yes, we conduct both in vitro and in vivo studies as required under REACH guidelines.
How experienced are you in REACH submissions?
We have completed and submitted more than 100 REACH packages to regulatory agencies.
Do you help ensure regulatory compliance for chemical safety?
Yes, our services support compliance with REACH regulations for safe use of chemical substances.
