Understanding the EU Regulatory landscape with Obelis’s consultancy services
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. With over 30 years of experience, we have guided thousands of manufacturers from all over the world with our Regulatory expertise.
Our Consultancy Services
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)
Our trainings: Strengthening Regulatory Knowledge
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, industrial and mechanical sector, protective equipment, technology and innovation, consumer goods, and other.
From general insights to the most challenging aspects, a few of our consultancy areas on which we also propose trainings are:
- European Authorized Representative, EU Responsible Person
- Technical File Creation, Review
- Product Registration, National Device Registration
- Vigilance, Clinical Evidence, Clinical Evaluation Report, Risk Management
- Product Classification
- Free Sales Certificates (FSC)
- Harmonised Standards
- Trademark Submissions
- Navigating Obelis’ information platforms (MDlaw and COSlaw)
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.
Our team of lawyers, chemists, pharmacists, and other experts represents the largest centre in Europe for CE Marking and EC REP services.
Founded in 1988, Obelis is certified by ISO 9001:2015 and ISO 13485:2016, and partakes in various EU associations and EU commission working groups.
