With our experience in Europe, North and South America, Asia and the Middle East we can help you to a rapid market approval in all regions. Whether for short or long term contracts – we can manage your product registrations for all target markets, supported by our in-house software REGULA™. We offer long-term experience in writing clinical evaluation reports.
Whether for short or long term contracts – we can manage your product registrations for all target markets, supported from our in-house software REGULA. We will drive the complete regulatory process. This includes monitoring your deadlines and expiration dates as well as overseeing the document transfer with the authorities or your on-site partners until the approval is obtained. Our vast practical experiences including some exotic markets is helpful for dealing with and navigating country specific requirements.
Based on our experiences, additional research and our worldwide network of experts we respond on your specific questions concerning Regulatory Affairs matters. We even have one native Chinese staff member designated for the China and Taiwan market space.
510(k), STED or CSDT format – based on your technical documentation we will compile submission dossiers in the format the target markets and Regulatory Affairs demand.
Many companies assess the importance of Regulatory Affairs only with regard to Time to Market and Compliance. Regualtory Affairs are often recognized as strategic business criteria and relevant for product entry into the market only in retrospect. With a neutral assessment and a Benchmarking by our team, you will receive position-fixing and specific suggestions for a better integration strategy with respect to the relevant Regulatory Affairs issues in your projects and processes.
For more information of this topic, you can refer to our Fact Sheet .
Our previous mandates in this sector are confidential.
By combining our regulatory professional knowledge and our competences in the sector of software development an application tailored for the management of regulatory activities gradually developed. Since autumn 2007 we have also offered this software to our customers.
More information about REGULA™ can be found here.