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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
Provider Logo

Provider & Contact

Provider Organisation HUMANI SC - Hospital network (HUMANI)
Provider Country Belgium
Published Email tefservices@humani.be
Billing: per hour
Full Price €70-91 EUR
Reduced Price €54-70 EUR
Pricing Detail

This price is based on the less qualified human resource who may perform the service. The final price will be determined in the contract between the service provider and the applicant.​

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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