Case Study: Streamlining IND Application Support for Drug Products
Challenge
A client approached Eurofins with an urgent need for testing to support their Investigational New Drug (IND) application for an orally delivered botanical drug product. The testing was critical for initiating phase 2 clinical trials. The project required innovative problem-solving, as no existing monograph was available for guidance, and the client faced pressing timelines to meet FDA requirements.
Solution
Eurofins leveraged its extensive expertise and capabilities to address the client’s needs:
- Regulatory Preparedness: Possessed a DEA license to handle controlled substances, ensuring compliance with stringent regulations.
- Specialized Expertise: Demonstrated proficiency with the specific drug matrix.
- Customized Testing Solutions: Developed and validated new methods tailored to the unique requirements of the drug product, performing comprehensive testing on raw materials, drug substances, and the finished drug product.
- Proactive Troubleshooting: Quickly adapted to FDA requests for additional testing by performing verification efficiently and effectively.
Eurofins provided full-service support, demonstrating flexibility to accommodate changing scopes of work, deliverables, and aggressive timelines.
Outcome
Eurofins’ reliable testing, technical support, and rapid response enabled the client to meet FDA requirements. The IND application received FDA clearance, an achievement that would not have been possible without Eurofins’ dedication and expertise. The successful outcome ensured the client could move forward with their phase 2 clinical trials, meeting critical development milestones.
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