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Drug Registration Management

Canton Biologics provides efficien火鐵t and accurate registration唱中 support, including domestic and 雜拿foreign IND (CTA)/BLA(MAA)/co為術nversion and other declaration servi見去ces. Our registration and 暗舊regulatory team has rich experienc了冷e in US and European registrati城金on filings, fully underst化多ands the laws and regulat空唱ions and communication mechanisms刀就 of various regulatory agenc體街ies, and can comprehen討請sively provide regulator姐答y and strategic guidance for cu黑國stomers throughout the life 計跳cycle of drug development. 謝制

Canton Biologics intends to provi光數de customers with a ful海舊l range of registratio務小n and regulatory services, 能林including CMC consulting services,時話 filing strategy support, hol什光ding scientific consult會鄉ation meetings, writing CMC-r船見elated CTD materials,鄉得 assisting in communication with r資媽egulatory authorities, assisting in 請答replying to review opinions and雜弟 supplementary infor著但mation submissions. We have th行笑e ability to write b通頻oth Chinese and Eng城森lish materials that meet the regist西村ration requirements of China, US a子書nd Europe, and have a wealth of succ體多essful experience in multi-countr學媽y clinical trial applications (IND樹鄉/CTA), new drug market applicatio嗎志ns (NDA/BLA/MAA) and conversion小聽 production in China, US and Europe.生說

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