We advise our clients to understand the regulatory landscape in the specific country (or region) of interests and we help to develop the regulatory strategy.
We advise our clients regarding Risk Classification of the medical device and regulatory pathway for the specific country (or region) of interests.
With respect to CE, we assist our clients to prepare the technical file and provide guidance with regards to their application for CE.
With regards to US FDA, we will work closely with our US consulting partner to provide their expert advice and also the local contact point for submission to US FDA.
Similarly with regards to China CFDA, we will work closely with our partners based in China to provide their expert advice and also the local contact point for submission to CFDA.
With regards to Singapore and ASEAN countries, we help our clients to prepare the ASEAN CSDT when needed.
Our consulting services have expanded beyond product registration and together with our strategic partners, we are moving towards the area of providing regulatory (and also QMS) advisory services to support clinical trials work.