The EU Regulatory landscape can be difficult to navigate. In addition to a complex system, laws are updated frequently, and new regulations are replacing existing directives. Staying up to date and be prepared for changes is crucial for manufacturers to be compliant and avoid breaches.

For both EU and extra-EU manufacturers, we offer consultancy and training services to help you understand and apply the appropriate EU legislation.

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The Representative of choice

Our consultancy services include:

  • Regulatory support and advice
  • Ensure compliant technical documentation
  • Evaluate claims and labels
  • Compilation of documents
  • Regulatory research
  • Updates on regulatory matters
  • Translations

This means your EU consultant will support you to:

  • Successfully penetrate the EU marketplace
  • Ensure compliant technical documentation
  • Conduct EU Research and Clinical Investigations
  • Evaluate EU Market Claims
  • EU Labeling & Translations
  • Remain up-to-date on legislative/economic/political matters that may influence your product compliance (i.e. Brexit)
  • Provide support in determining an effective overall EU Market Strategy (i.e. distribution, warehousing, etc)

To strengthen your knowledge on the EU Regulatory system, we offer trainings on a wide range of topics. We can guide you through various Regulatory matters with online or on-site trainings. Some of our strongest areas of expertise are medical devices and IVD medical devices, cosmetics, food supplements, aesthetic devices, electronics, protective equipment, and other.

From general insights to the most challenging aspects, a few of our consultancy areas on which we also propose trainings are:

In addition to trainings, we offer various webinars held by our experts. On both Obelis website and Obelis’ information platforms, MDlaw and COSlaw, you can find a vast selection of webinars.

Compliance Success Stories

Why Obelis?

Our deep and long-standing experience with Swiss, EU and UK compliance frameworks makes us the best choice to support your products’ path towards compliance in these territories.

Our team regulatory experts will guide you through medical devices’ technical documentation, notification, labelling, among others.

About us
Founded in 1988, we are among Europe’s largest centres for advisory and representative services.
We are certified by ISO 9001:2015 and ISO 13485:2016.
We have helped over 3,000 manufacturers from over 60 countries address their regulatory challenges.
We are members of professional associations and more than 10 European Commission working groups.
Obelis International Offices (OIO) comprise independent partners providing solutions in other global markets.
Our team consists of lawyers, chemists, pharmacists, and other experts. Our close-knit culture has been certified by the Great Place to Work Survey 2022-23.