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Regulatory Affairs

Bioworkshops regulatory affairs services focus on biologics CMC (chemistry, manufacturing and controls) document preparation and biological drug applications in China, the United States, and Europe. We design and execute registration strategies for each project according to our clients’ specific goals.

Bioworkshops efficiently utilizes CTD templates and other formats and integrates them into drug registration processes, including meeting with authorities, application filing, registration, on-site inspection under MAH guideline.

Services

Entire CMC dossier writing to countenance INDs and BLAs
Staged regulatory meetings with authorities, such as PIND meeting, EOP2 and EOP3
IND/BLA dossier writing in CTD format or other formats based on our clients’ requirements
eCTD filing
Chinese agent for foreign companies for pharmaceutical product import license in China
Submitted documents translation
Provide assistant to our clients on Pharmaceutical Product Manufacturing License Application under MAH in China