With Harald Studer
The core of Optimeyes was successfully validated
Regulatory Affairs – from selective consulting to outsourcing
Despite all the efforts of the various international agencies to harmonization the Regulatory Affairs, international approvals are continuing to become more complex and elaborate. Understanding the process and updates to the regulations improves your Company’s efficiency and can be recognized as a competitive advantage. Our worldwide practical experience with product registrations helps you to have streamlined approvals within the frame of your aspired Time to Market.
RA-Management – Per Request or Long-Term Contracts
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.
Submission Dossiers for your Product Registrations
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.
Assessment and Benchmarking of your Regulatory Strategy
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.
Combination Products and IVD
Our previous mandates in this sector are confidential.
REGULA™, Software to simplify the Regulatory Management
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. Here you will find the fact sheet about REGULA™ and the article from the September edition 2009 of the Device Med.