Meditrial successfully represents many global life sciences companies as their U.S. Agent. We assist with communications between the FDA and the company, scheduling of FDA inspections at the manufacturer’s site, solving import detention issues, and any other compliance questions that may arise.
UK RESPONSIBLE PERSON
If you are a manufacturer based outside the UK and wish to place a device on the UK market, you will need to establish a UK Responsible Person who will be responsible for your product in this country. Meditrial, with an office in London, can carry out all the tasks related to marketing of a device in the UK.
Using the industry’s best practices and high-end expertise, Meditrial’s specialized team offers Swiss Rep services and regulatory support for compliance with the Swiss Regulations and applicable requirements. Trust us to keep market access in Switzerland for your device.
DATA PROTECTION OFFICER
The DPO is an officer with expert knowledge of data protection.
Meditrial will take care of your GDPR compliance, IT security and Communication activities.
We are experts in managing internal policies, handle complaints and requests, raise awareness, identify data processing activities and give advice & recommendations.
EU GDPR REPRESENTATIVE
Meditrial can be your EU-GDPR Representative and help you:
- Serving as the contact point for data subjects and supervisory authorities for all issues on data processing within the study
- Ensuring overall GDPR compliance
- Preparing GDPR compliant study documentation and regulatory submissions
- Assisting with developing internal procedures for handling subject rights and data breaches, managing data subject rights requests, and reported data breaches
Meditrial has helped over 500 start-up and mid-size companies gain a foothold in Europe. Acting as a strategic partner, we help you comply with the European legal requirements and establish constructive relationships with Competent Authorities, Notified Bodies, hospital networks, the European Commission, and industry associations.