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Clinical Research Services - Regulatory support

Physical
Unique Identifier: a1b44083-fc97-4b9e-a710-e703543891a6

Service Description

Assisting in regulatory submissions in compliance with applicable laws and requirements. Providing with the necessary regulatory documents. Performing regulatory submissions. Liaison with regulatory bodies: Ethics Committees (EC), Federal Agency for Medicines and Health Products (FAMHP), European Medicines Agency (EMA).

Offerings: Testing Clinical (investigation, trial, etc.) Clinical Investigation Support (clinical studies & trials, coordination, design, feasibility, documentation, compliance, operations support, etc.)
TEF-Health Use Case Domain: all
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Provider & Contact

Provider Organisation HUMANI SC - Hospital network (HUMANI)
Provider Country Belgium
Published Email tefservices@humani.be

Pricing is available to registered users. SMEs receive significant state-aid reductions (GBER) — or, depending on the call, free services during the funded project. Sign in or register to see the price for your organisation.

Operational Details

Service Inputs Medical device documentation; Feasability report; Research team proposal; Preliminary synopis; Project draft; Essential documents; Investigation team documents
Service Outputs Regulatory document templates ; Completed regulatory documents; Regulatory submission performed
Dependencies & Restrictions  
Certification Support  
Service Standards
  • Artificial Intelligence Act
  • Belgian national laws
  • EU regulations: Medical Devices
  • GDPR
  • IATA
  • International regulations: Good Clinical Practice (ICH-GCP)
Comments  

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