A large Pharmaceutical company was facing major challenges when importing their centrally sourced comparators into China. Working with their CRO and CMO there was a lack of understanding of the regulatory and import specifications in China, which had caused them to have product held up and import license applications rejected, which ultimately led to them having to delay dosing in the study.
Utilising our global partners and our in-house regulatory expertise, Bionical Emas was able to provide a fully mapped out solution to ensure product was delivered into China. Through working with the manufacturers in the EU, we were able to access the required first leg documentation and other supporting documents (CoA and CoO) to ensure a smooth import license application process. Utilising our partnership with our local broker and logistics partners, Bionical Emas managed the import license application process and successfully received this from the CFDA in 24 hours of receiving all required documents. As a result, our client was able to significantly reduce the delays in the study and ensured a reliable route for future re-supplies.