Supporting chemical safety and environmental protection through robust REACH compliant solutions.
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.
In addition to the tests performed under Annex VIII (10 Tonnes or More), other tests include:
In addition to the tests performed under Annex IX (100 tonnes or more), another test includes:
We are the first GLP-accredited laboratory in India and have been successfully audited by the USFDA (2012 and 2016) for GLP studies submitted as part of IND/NDA packages.
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).
With over 1,100 clients and 30+ years of drug development experience, we bring a strong track record in regulatory submissions and safety assessment. Our scientists work as an extension of your team to accelerate preclinical development and deliver quality data for key decision-making.
Global Clients
Years Experience
Investigational New Drug
(IND) packages submitted
Investigational New Drug (IND) packages submitted
We provide comprehensive REACH compliance support, including study execution and IUCLID dossier submissions.
We support studies across all tonnage bands from 1 tonne to 1000+ tonnes.
Yes, we conduct both in vitro and in vivo studies as required under REACH guidelines.
We have completed and submitted more than 100 REACH packages to regulatory agencies.
Yes, our services support compliance with REACH regulations for safe use of chemical substances.