EU Consultancy, Legal & Training
Find your way through a complicated EU marketplace with the support of a professional.
Are you a EU-based manufacturer looking to lighten your Regulatory load by taking advantage of our EU Commission involvement and 30 years of Regulatory expertise?
Or perhaps you're a non-EU based manufacturer looking to successfully navigate the complexities of the EU Market and want to lean on a professional in order to remain focused on sales and business development.
Your EU Consultant will help you:
- 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)
Contact Obelis to see how we may be able to help.
EU Consultancy & Training Services include:
- EU Consultancy
- European Authorized Representative / EU Responsible Person
- Technical File Creation / Review
- Product Registration
- National Device Registration
- Regulatory Updates
- EU Market Strategy
- Product Classification
- Formula Review / Validation
- Free Sales Certificates
- Essential Requirements Checklist
- Identification of Harmonized Standards
- Clinical Evidence / Clinical Evaluation Report
- Risk Management
- GMP Self-Declaration (Cosmetics)
- Trade Mark Submissions
- On-Site Visits / Training
Supporting you with ad-hoc legal matters
Do you want to have your trade mark protected for the whole EU territory or in the UK? Do you need a review of the quality agreement you have in place with your importer and distributor under the MDR or IVDR? Do you use the personal data of people in the EU and wish to know if the GDPR applies to you?
Obelis can provide you with legal services to support your EU operations.
Our legal services:
- Conducting legal analysis of EU laws
- Issuance of official statements
- Review of agreements and provision of templates
- EU trademark registration with the EU Intellectual Property Office (EUIPO)
- Trademark research and clearance
Assisting with General Data Protection Regulation (GDPR) matters
If you are established in the EU and processing personal data anywhere in the world, or if you are not established in the EU but you are processing personal data for people in the EU, then GDPR applies to you.
- Applicability assessment and consultancy
- GDPR Representative services to manufacturers processing data of, among others, Belgian subjects
Get in touch