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临床和商业化产品生产服务
制药

临床和商业化产品生产服务

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YOUR LONG-TERM MANUFACTURING PARTNER

Novasep specializes in the contract manufacturing of APIs, cGMP and non-GMP intermediates from kilograms up to hundreds of metric tons.

Novasep API Production Workshop

Thanks to excellent technical  transfer capabilities, your process is rapidly implemented in our facility for a rapid and efficient production.

We put a strong emphasis on operations to deliver your project on time, in full and within specification. This has resulted in our strong track-record of right-first-time and on-time-in-full delivery and has made Novasep a reliable long term partner to manufacture your compounds.

FACILITIES AND TECHNOLOGIES TO DELIVER YOUR COMPOUND

All of our five chemical production plants are regularly audited by the FDA and by local authorities, all of which have established a strong quality track record over the years. These facilities are closely connected and benefit from shared resources for Project Management or R&D for instance. Centralized Directors of Operations, R&D, Project Management and QA ensure a global and systematic approach. They also allow for exchanges on complementary know-how for each production site to benefit from the right synergy of expertise, including energetic chemistry, the handling of compounds with high potency, advanced purification services, chiral technologies and a wide range of advanced organic synthesis reactions. Visit the technology center to learn more.

Our network of facilities also allows for a multi-site strategy with an access to the chromatographic purification platform worldwide and the possibility to validate a back-up production plant to further secure the supply chain.

 

Novasep Prochrom HPLC Column In Operation

RAW MATERIAL SOURCING STRATEGY

Our sourcing team is spread across Europe and Asia, with a close connection between the teams on both continents to provide optimized sourcing. The European team is in direct relation with the operations on site to identify precisely the needs for raw materials and connect with Eastern raw material suppliers. In China, the Shanghai-based team has established a network of reliable suppliers in Asia that we regularly audit, to access competitively priced raw materials and intermediates.

COMPLEMENTARY SERVICES

Our offering also includes full regulatory support, process development, analytical validation and support and continuous improvement. We can even design and implement together your own dedicated production plant at Novasep. Contact us for more information.

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