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.

Our previous mandates in this sector are confidential.

International RA-Intelligence relieves your organization

ISS maintains a very well developed worldwide knowledge management. This makes it possible to create RA Intelligence tailored to your company and to make your RA processes and ultimately your company more efficient and cost-effective. The various elements ensure that you have a better grip on RA issues and that your staff is adequately trained.

Your Benefit

• Reduced load owing to tailoring to your products and markets
• Systematic training of your employees
• Ongoing preparation for the new EU regulation MDR
• Up-to-date information on international markets outside the EU and USA
• List of Applicable Standards always up-to-date
• Keep an eye on the Vigilance
• No costs for expensive databases
• Calcualable costs

Customer Opinion

“The RA-Intelligence Services from ISS help us to focus on our core business and give us the security not to miss important changes. Furthermore, the combination with internal trainings unburdens our RA/Q department, improves our efficiency and increases the credibility towards our auditors.”
Stefan Römer,VP RA&Q, Belimed AG, Zug

Regulatory Training

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.