We are authorised agent AR for manufacturers located outside EU.
Registration No. SE-AR-000001888.
Do you need one? Contact us today!
We are Person Responsible for Regulatory compliance, PRRC in several countries like Denmark, Germany, The Netherlands and Sweden! Contact us to get further information
We have developed a very cost effective and time saving way for our customers to get into and ensure compliance!. This is typical very helpful for startups!
Market access strategy, Handling of authorities and compliance projects.
How should you think when you organize the Quality and regulatory affairs organization, global vs local to get out most of it.
We can assist and/or drive regulatory affairs related activities around the world. A few examples are product submissions, post market surveillance, Authorized representative, labeling and promotion control.
We do most kind of quality related activities covering FDA´s QSR and quality standards such as
ISO 13485, ISO 9001 and environmental standard ISO 14001.
We have extensive experience in:
- All product classes
- Notified Bodies
- EU task forces
- We are Authorised Representative
- Technical documentation
- We are PRRC
We have extensive experience in handling FDA issues and submissons including FDA inspections, 510(K) De Novo and pre submissons
We have long experience working in upper management positions driving company strategies and implementing management systems globally
We can help you to map the requirement and how they will effect your business, What to do when and what alternatives you have. We often start the process with product classification and a gap analyse to ensure the right starting point!
Yes, in fact most activities we do can be done remotely. One of the biggest factor in why the way we work is fast and efficient for the customer is because we design the possibility to work remote! This save both time and money.
If you want to get things done and not pay more than you need we will be a perfect match. We typical offers several packages where you can choose level, Bare minimum, Good enough or Best in class! and by the way we will be around and support you not only during the work, but also afterwards!
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