Communicate – Iterate – Simplify
Entering a new market requires an understanding of the regulatory framework, good technical documentation and efficient processes for preparing applications and answering questions from regulatory authorities.
To achieve a broad market introduction you need a solid structure and good communications with authorities and local representatives.
Our consultants are results-oriented and are accustomed to navigating the global environment, both traditional and emerging markets. Today, we work primarily with medical products and offer services in the following areas:
- Market Access
- Preparation of submissions worldwide & CE-marking
- Preparation of submission plans
- Coordination/management of submission activities
- Post market reporting
- Authority reporting of complaints
- Authority reporting of field corrective actions
- Submission Planning
- Adapting processes to a changing regulatory landscape
Training in Regulatory Affairs
Find upcoming Regulatory Affairs and MedTech training opportunities here » (Swedish only)