End-to-End Testing Services to Support Compliance, Safety, and Market Access.
Integrated Biocompatibility and Safety Assessment Testing to Meet Global Regulatory Requirements
We help develop an appropriate biological evaluation program for assessing the safety of medical devices as per the latest ISO 10993 standards, FDA guidance document and other relevant guidelines, while performing all studies in compliance with GLP and ISO 17025 to ensure worldwide acceptability. Our medical device testing team has an accumulated experience of 100+ years in biological safety assessment, and biocompatibility testing strategy.
Adgyl Lifesciences is your ideal partner for providing medical device testing services, including data that can be used for 510(k) submissions and to various other regulatory and notified bodies.
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).
We deliver validated, submissionready SEND datasets via the FDA-required Submit™ platform
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.
Clients
Years Experience
Investigational New Drug
(IND) packages submitted
Investigational New Drug (IND) packages submitted
We offer end-to-end biocompatibility and safety assessment testing services.
Yes, all studies are conducted as per ISO 10993 standards, FDA guidance, and other relevant guidelines.
Yes, we provide data suitable for 510(k) submissions and other regulatory and notified bodies.
Yes, we are accredited for biocompatibility testing.
Yes, all testing is performed in compliance with GLP and ISO 17025.