China Regulatory Affairs
The Chinese market is large, diverse and full of opportunities – but it can also be a challenging one.
Having an experienced partner by your side is essential to guide you through the regulatory process of pharmaceutical drugs and medical devices in China and help you to succesfully interact with Chinese authorities.
China Regulatory Affairs
The Chinese market is large, diverse and full of opportunities – but it can also be a challenging one.
Having an experienced partner by your side is essential to guide you through the regulatory process of pharmaceutical drugs and medical devices in China and help you to succesfully interact with Chinese authorities.
Our advisory services
Communication with health authorities
Interacting with the local health authorities not only requires a detailed knowledge of the Chinese regulations but also familiarity with the Chinese language and communication customs.
Our Chinese speaking consultants will communicate with the Chinese authorities in person, via e-mail and phone and prepare all necessary meetings for you.
Clinical Trial Application (CTA)
The clinical development process can be costly and tedious.
We offer a variety of services to shorten your clinical trial journey, such as: Product development strategy, personalised agency interaction and communication strategy, CTA submission and dossier compilation, sample testing management and forming liaisons with all relevant Chinese agencies - acting as your local representative.
Regulatory intelligence
All through your regulatory process we gather, analyse, update and interpret the Chinese regulatory laws, regulations, guidances and announcements.
Furthermore, we provide you with customised intelligence reports, tailored to your exact and individual needs.
Marketing Authorisation Application (MAA)
We provide you with expert support on Marketing Authorisation Application (MAA).
We help you forming a regulatory pathway optimization strategy, creating package insert wordings, compiling MAA submissions and dossiers and managing sample testings.
Post-approval life cycle management
Our consultants guide you all through the way with an end-to-end regulatory lifecycle support.
This includes the preparation of variation applications, the submittance of variation dossiers to the health authorities and the maintenance of licences.
Contact us
Talk to an expert
Contact us for more information or to request a free, no-obligation proposal.