SOVPHARM

Sovereign emphasizes the development and filing of ANDAs, INDs, and 505(b)2 NDAs. We offer expert services in all aspects of the development process for filed products. We perform all stability studies under ICH guidelines, assemble the CMC section, and file the applications in eCTD format with the FDA on our customer's behalf. Our talented R&D organization has the experience to match the desired bioavailability of immediate-release and sustained-release products to expedite your time to file and reach approval. Our regulatory staff has the expertise to monitor biostudies if required. Our experienced Business Development and Regulatory Affairs team can assist you in designing a unique product with minimal clinical requirements... At Sovereign, it's about the customer. We maintain the highest standards in the industry specifically to provide our customers with the best results available... Sovereign - Your CDMO for liquid medicine solid dose manufacturing, tablet pressing, product..

Primary location: Fort Worth United States