Regulatory Expertise at Octa Impex
At Octa Impex, our Regulatory Affairs Department is a key asset, developed through years of experience and continuous growth. We have built a deep understanding of regulatory frameworks and requirements across diverse geographic regions, including some of the most complex markets like China, Brazil, and Japan.
Our regulatory expertise is rooted in decades of hands-on experience, allowing us to navigate the global regulatory landscape with confidence. We focus on providing strategic consultancy, ensuring transparency, and delivering continuous feedback to our clients for both generic supply and specialized CDMO (Contract Development and Manufacturing Organization) projects.
Our Regulatory Affairs team, made up of 35 highly qualified professionals based in Europe and Asia, offers unparalleled support to our customers. We have successfully facilitated numerous submissions worldwide, aiding in marketing authorizations and clinical trials. Our deep knowledge of international regulatory frameworks allows Octa Impex to provide exceptional service within the industry.
Customer-Focused Regulatory Excellence
- Centralized Regulatory Process: Managed at our headquarters, offering seamless service to partners throughout the entire regulatory process.
- Single Point of Contact: A dedicated regulatory expert supports each partner from start to finish.
- Strong Expertise: Our team’s vast knowledge and skills provide clients with superior guidance.
- Global Reach: We handle Drug Master Files (DMFs) within and outside ICH (International Council for Harmonisation) guidelines, covering every geographic region.
- Complex Markets: We expertly manage regulatory submissions in areas with the most stringent systems, including Latin America, the Far East, China, Russia, Japan, WHO regions, Africa, and Australia.