Regulatory Expertise
At Bilim Pharmaceuticals, based in Istanbul, Turkey, our Regulatory Affairs (RA) Department is a cornerstone of our operational success, reflecting significant growth and diversification in expertise across various global regulatory frameworks. With deep-rooted knowledge spanning decades, our team is adept at navigating the complex regulatory landscapes of key markets including China, Brazil, and Japan.
Our RA team consists of 35 highly skilled professionals strategically positioned in Europe and Asia, providing expert consultancy, ensuring transparency, and maintaining continuous communication with our clients on both generic and CDMO projects. This approach not only streamlines the regulatory process but also enhances the service we provide to our partners, offering a single point of contact throughout the regulatory journey.
Key Highlights of Our Regulatory Expertise:
- Centralized Regulatory Processes: All regulatory activities are centralized at our headquarters to maintain consistency and high standards.
- Global Coverage: We expertly manage regulatory submissions across all geographic areas, accommodating the stringent requirements of diverse regions including Latin America, the Far East, China, Russia, Japan, WHO-regulated territories, Africa, and Australia.
- Document Submission and Management: We efficiently handle Drug Master Files (DMF) both within and outside the ICH regions, showcasing our capability to support marketing authorizations and clinical trials worldwide.
Through our dedicated RA department, Bilim Pharmaceuticals reaffirms its commitment to maintaining the highest standards of compliance and supporting our clients’ needs with precision, thereby reinforcing our role as a leader in the global API industry.