Case Study: IND-enabling safety tox studies for FDA submission in just 9 months
Why It Matters
Delivering IND-enabling packages is a race against time. By combining deep scientific expertise, cross-functional collaboration, and regulatory know-how, Syngene helps accelerate your path from discovery to the clinic.
Case study details
The Client
A clinical-stage pharmaceutical company advancing novel therapies through a proprietary lipid-signalling platform, with a lead molecule targeting painful neuropathies including chemotherapy-induced peripheral neuropathy (CIPN).
The Requirement
To progress their lead molecule, the client needed a full IND-enabling safety tox package for submission to the USFDA. The challenge: complete all studies to stringent GLP standards within nine months.
The Studies Included
- Safety pharmacology: CNS, cardiovascular, and respiratory assessments
- 35-day repeat dose toxicity studies in rats and dogs
- Genotoxicity testing
- Analytical and bioanalytical validation
- SEND dataset preparation as per FDA standards
Our Approach
- Designed an integrated study plan to run multiple GLP studies in parallel
- Selected appropriate species, doses, and vehicles based on DRF studies
- Characterized test articles under GLP guidelines
- Conducted analytical validation for formulation and TK matrix
- Ensured CTD-compliant documentation throughout
The Outcome
All required studies were completed in just nine months, enabling the client to submit their IND application to the FDA on time.
- FDA IND clearance was granted for their neuropathy program
- Phase 1 clinical trials are now underway
- The client continues to partner with Syngene for upcoming safety assessment studies
Delivering IND-enabling packages is a race against time. By combining deep scientific expertise, cross-functional collaboration, and regulatory know-how, Syngene helps accelerate your path from discovery to the clinic.
Let’s talk about your IND program
Meet our experts at CPHI Frankfurt to explore how Syngene can fast-track your development timelines
Who You’ll Meet
Peter Bains
Managing Director and CEO
Caroline Hempstead
(Interim) Chief Commercial Officer
Pramuch Goel
Head of Corporate Affairs
Alex Del Priore
Head of Large Molecules CDMO and (Interim) Head of Small Molecules CDMO
Mrinal Kammili
Head of Translational & Clinical Research
Gopi Krishnan
Vice President, Biopharmaceutical Manufacturing
Sudhir Nambiar
Vice President, Drug Substance Development and Manufacturing
Manoj Babu
Vice President, Business Development
Jeffery Wong
VP Sales, Biologics
Julien Hugon
Vice President, Business Development
Rajkumar Agarwal
General Manager,
Business Development
Manoj Babu
VP, Development Services
The Syngene Advantage
Quality Focus
We are a fully digitized quality organization with a strong compliance track record with global regulators. Our facilities are US FDA, EMA, and PMDA approved, GLP certified, and AAALAC accredited.
Sustainability
As part of our commitment to sustainability, we recycled 63% water, consumed 92% renewable energy, and recycled 95% waste. We had zero environmental violations, and we won the TIME Magazine award for being the most sustainable pharma company in India, and in the Top 20 globally.
Green Chemistry Innovation
Implemented green chemistry across process design, process development, execution, and disposal phases. Also, reduced raw materials, solvents, waste, and disposal.
Robust Supply Chain
A network of 2500+ suppliers across 30+ countries, contracts with global partners, 24X7 local arrangements, and extended support to local partners. Plus, expanded biologics capabilities with our new facility in Bayview, Maryland, U.S.
We look forward to meeting you in Frankfurt.
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