Synowledge’s global submissions services measure a company’s operations across the world against the requirements of all respective regulatory bodies. We work with you throughout the development, MA approval, and post-approval (variations, updates, notifications, etc.) phase by helping you prepare, submit, and follow-up on all submission content to applicable regulatory bodies. Our extensive knowledge of national and international standards, coupled with our attention to detail and commitment to excellence, help you to get your products to approval and to market.
Abridged Applications, ANDA, OTC, health supplements, complementary medicines application submissions
Marketing Authorization Applications
Filing Variation IA, IB and Type II through MRP, DCP or National Procedures
Renewal Applications
Global Clinical Trial Applications Phase I to Phase IV
Medical devices dossier submissions
Dossier filing through MRP, DCP and National procedures
Managing Product Life Cycle throughout its shelf-life
Import and Export License applications (Clinical trial Drugs, Biological Samples)
