Process Capability : Sundia has been providing process development and scale up production service since 2004. Our services include the laboratory works such as process research and small scale synthesis of APIs which are used for preclinical and pre-formulation studies. Our services further extend to relatively large scale kilo lab synthesis as our client's program moves to phase I clinical studies. At this stage, we can help client identify the synthesis route and optimize the process, followed by non-GMP and/or GMP-required synthesis of intermediates and APIs. As your clinical program moves forward, we can make more intermediates and APIs to support your Phase II and III clinical trials and commercialization needs in our production site.
We also provide service for our clients to develop better and/or n
After-sale Service : Analytical Development (ARD) is to support Chemical Process Development and Formulation Development during the pharmaceutical development. ARD offers GMP compliant Analytical testing services to the pharmaceutical and biotech companies. We are equipped with state-of-the-art analytical instruments. We deliver fast and reliable results and help our clients to achieve their goals of registration.
Sundia ARD team offers a wealth of experience and expertise in every aspect of analytical support ranging from method development to regulatory submissions. Our team also has experience with SFDA filing to get Clinical Trial Approval in China.
Key Services:
? Method development and validation for starting material, intermediates, API, and dosage forms
? Assay/potency
? Impurity/degradat