Custom Process Research Services/ Custom Manufacturing Services

Drawing on our diversified technical know-how, ScinoPharm provides custom process development for early phase API activities from small molecules to large ones.

Our integrated custom research and manufacturing services enable streamlined technology transfers and project administration, which in turn helps customers speed up their drug development and supply projects.

With cGMP and FDA inspected facilities in all scales as well as built-in quality management systems, we are proud to provide the following services:

• Exclusive syntheses of pharmaceutical intermediates and active ingredients
• Process research & development of optimal synthetic routes and processes
• Process scale-up and process validation
• Analytical testing method development & validation work
• Material supplies beginning at the IND stage and continuing through clinical needs as well as launch and post-launch supply requirements
• Contract manufacturing from kilos to tens of tons of APIs and regulated intermediates
• Stability testing program meeting ICH standards
• Regulatory filings worldwide

We have core competences in four areas and ensure their successful integration via our Project Management system.