About us
Our story began with a discussion among enthusiastic friends in the field of medical device as senior regulatory manager, quality manager, testing engineer, clinical writer and authority reviewer how to build up a platform sharing our interdisciplinary expertise.
We crystallize the aim of the platform: make the medical device approval transparent for EVERY manufacturer complying with the Chinese regulatory requirements, share our experience and work with joy, passion and satisfaction.
We heard also the needs of matching healthcare investors, Chinese distributors, suppliers and even Chinese production sites.
Besides the focus on regulatory affairs service of medical device, we will provide services at the whole Chinese commercialization of medical device in customer need.
We have also international offices and partners to contribute to other globe regulatory affairs services.
Premium Regulatory Affairs Partner
Why us
- All of our Chinese colleagues speak fluently English, even German. We don`t need English mother tongue personals without Chinese regulatory knowledge in between.
- The colleagues with most experience in your product group will be chosen at your NMPA registration.
- We extract efficiently the contents into Chinese templates because we have sound knowledge in technical documentation in EU and US.
- No un-estimated troubles will be escalated, because we work in a risk-based manner. All potential troubles are analysed and prepared.
- We work upon our schedule, in every milestone you get the summary of project approach in details.
- You get all original Chinese certificates and documents so you are flexible with own authorization after product approval
Our Mission
Loyal
We appreciate working with you. The key of success is based on our trust and faith. We commit ourselves with all efforts to deserve to be your partner.
Transparent
The intercultural and interdisciplinary communication is a kind of art. We are trained to communicate smoothly and transparently accelerating access
of medical technology into Chinese market.
Easy
The regulation is made and complied by human-being. Our philosophy is to be
Chinese voice to
make the complex, sometimes up-regulated legislatives of medical device easy to understand and so that legal manufacturer can proactively implement it.
Premium
We endeavour to be a
premium partner with quality and enthusiasm. It is our task to expedite
innovative medical device available to all patients.
