EU Consultancy & 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
• Vigilance
• 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
• MDlaw.eu