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We have a experienced, dedicated global regulatory affairs service team who provides CMC services for global customers in the Drug's whole lifecycle, including Investigational New Drug Application (IND/CTA), New Drug Application (NDA/MAA) and Abbreviated New Drug Application (ANDA), post-approval regulatory services such as variation, annual report and re-registration etc.
● Clinical trial applications
We specialize in assisting clients with various aspects of the drug development process. Our RA team is experienced in handling clinical trial applications and can guide you through each stage of the process. From initial planning to final submission, we ensure that all necessary documentation is prepared accurately and efficiently.
● New drug&Generic drug application
Our experts are well-versed in regulatory requirements and can assist you with compiling the necessary data and documents for submission.
● Product changes,Annual reports&Re-registration
Once your product is on the market, we offer comprehensive maintenance services including managing product changes such as formulation modifications or labeling updates. Additionally, our team can assist with preparing annual reports required by regulatory authorities as well as any re-registration processes that may be necessary throughout your product's lifecycle.