Pharmaceutical & Biotechnology
Comprehensive drug development services for small molecules and biologics, including small molecules drug substance manufacturing.
Industry Focus
Integrated drug development services for Pharma and Biotech
Adgyl Lifesciences offers a wide range of drug development services to pharmaceutical and biotechnology companies with small molecules and/or biologics in their pipeline. The services include but not limited to, medicinal chemistry, ADME, in vitro and in vivo pharmacology, safety assessment, bioanalysis and CDMO.
The services offered may be exploratory in nature, under non-GLP, or regulatory in nature, under GLP compliance. We also offer non-GMP and cGMP synthesis services for early and late clinical development.
Core capabilities
- Medicinal Chemistry
- ADME
- In Vitro and In Vivo Pharmacology
- Safety Assessment
- Bioanalysis
- CDMO
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).
- Regulatory-Ready SEND Data
We deliver validated, submission-ready SEND datasets delivered via the FDA-required Submit™ platform
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.
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 drug development services do you offer?
We provide end-to-end services including medicinal chemistry, ADME, pharmacology, safety assessment, bioanalysis, and CDMO.
Do you support both small molecules and biologics?
Yes, we support development programs for both small molecules and biologics.
Can you handle early and late-stage development?
Yes, we offer services across exploratory, preclinical, and clinical development stages.
Are your studies GLP compliant?
We provide both GLP-compliant regulatory studies and non-GLP exploratory research.
Can you customise services based on project needs?
Yes, our services are flexible and tailored to the specific requirements of each program.
