Dallas-based with a Global Reach
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.
Sovereign remains focused on the customer. We continually upgrade our equipment and facilities to meet the demands of our customers. We hire experienced professionals to take us into the future as a first-class pharmaceutical company. When you sign a contract with Sovereign, you can have the peace of mind that we will handle the entire process and deliver to you a quality product within budget and on time. We invite you to visit our facilities and welcome the opportunity to discuss how Sovereign can meet your development and production needs.
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