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Drug Registration Management

Canton Biologics provides efficient and accurate registration support, including domestic and foreign IND (CTA)/BLA(MAA)/conversion and other declaration services. Our registration and regulatory team has rich experience in US and European registration filings, fully understands the laws and regulations and communication mechanisms of various regulatory agencies, and can comprehensively provide regulatory and strategic guidance for customers throughout the life cycle of drug development.

Canton Biologics intends to provide customers with a full range of registration and regulatory services, including CMC consulting services, filing strategy support, holding scientific consultation meetings, writing CMC-related CTD materials, assisting in communication with regulatory authorities, assisting in replying to review opinions and supplementary information submissions. We have the ability to write both Chinese and English materials that meet the registration requirements of China, US and Europe, and have a wealth of successful experience in multi-country clinical trial applications (IND/CTA), new drug market applications (NDA/BLA/MAA) and conversion production in China, US and Europe.

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