MARKET ACCESS.

ACCESS KEY MARKETS

Meditrial accelerates the pathway to approval of life-changing devices, therapies and health technologies.

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POST MARKET.

ACCESS KEY MARKETS

Meditrial accelerates the pathway to approval of life-changing devices, therapies and health technologies.

MARKET ACCESS SERVICES

Meditrial is the Representative trusted by more than 100 firms.
Market access has never been easier.

MARKET ACCESS

U.S. Agent for Pharmaceutical & Medical Device Manufacturers.
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.

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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.

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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.

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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.

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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

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MeditriAl offers experienced EU QPPVs and Deputy EU QPPVs with extensive knowledge and experience of the industry. The marketing authorization holder (MAH) is legally required to have permanently and continuously at its disposal an appropriately qualified person responsible for pharmacovigilance in the EU (EU QPPV). You can rely on Meditrial to fulfill all EU QPPV functions.

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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.

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Quality System Support

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Labeling
Validation

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Device
Registration

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Vigilance Surveillance

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Free Sales Certificates

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Compliance
Audit

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In-Country Representation

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Post-Market Surveillance

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MARKET ACCESS & COMMERCIAL SOLUTIONS

Meditrial’s comprehensive suite of commercial services powered by Data & Analytics drive value creation and commercial success.

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Create informed strategies from early development through commercialization

Improve patient outcomes and identify opportunities to lower total cost of care

Inform healthcare and clinical decision-making to accelerate access

Generate regulatory-grade evidence to quantify the economic and clinical value

  • Market Landscape Assessment
  • Early Commercial Evaluation
  • Market Segmentation
  • Stakeholder Mapping
  • Payer, Provider and Patient Surveys
  • Policy Research, Analysis and Strategy
  • Coverage, Coding and Reimbursement
  • Competitive Analysis, Pricing and Payment
  • Health Economic and Financial Models
  • Claims Analysis and Payment Modeling
  • Research on HTAs and Clinical Trials
  • Real World Evidence
  • Observational Research & Surveys
  • HEOR Strategy and Gap Analysis
  • Manuscript Writing, White Paper & Green Book
  • Global (multi-country) Access Strategy
  • Coding and Reimbursement Applications

Your representative for Pharma and Medical Devices in Europe and USA.

Why Meditrial?
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