Meeting The Requisite Packing And Labelling Needs For A New Botanical Drug's Blinded Studies

A pioneering start-up in botanical drug development faced the critical challenge of ensuring GMP compliance and blinded clinical trial supplies for their Phase I trial in New Zealand. Douglas CDMO's expertise in drug development and regulatory requirements, coupled with their existing GMP infrastructure, provided the essential support for Evithé to navigate the complexities of the process.

The project demanded meticulous attention to detail, as the botanical tincture required cold chain storage and was classified as a dangerous good. Douglas CDMO's cross-functional team, comprised of experts in health and safety, quality, and client services, devised a comprehensive plan that effectively addressed these challenges while maintaining cost-efficiency. The CDMO's bespoke approach, characterized by open communication and proactive risk management, played a pivotal role in ensuring the timely and successful execution of the project.

Discover how a CDMO partner with integrated services enabled a botanical drug start-up to commence their Phase I clinical trial, paving the way for further advancement of their innovative botanical drug. The successful collaboration between the two companies underscores the importance of strategic partnerships in the realm of drug development, where navigating regulatory hurdles and ensuring product integrity are paramount.