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Clinical Research Services - Regulatory support

TEF-Health Service
Physical Consulting
Unique Identifier: a1b44083-fc97-4b9e-a710-e703543891a6

Service Description

OVERVIEW : Regulatory support consists in the preparation, the management, and the maintenance of regulatory and ethics submissions in Belgium, approvals, communications, and compliance activities required to conduct a clinical investigation in accordance with applicable regulations, ethical requirements, and Good Clinical Practice guidelines. Our service includes support during audits or inspections, and liaison with regulatory bodies: Ethics Committees (EC), Federal Agency for Medicines and Health Products (FAMHP), European Medicines Agency (EMA).

HOW CAN THE SERVICE HELP YOU ? : This service helps the SME navigate and manage the submission process with the Belgium regulatory authorities, ensuring that the required documentation is submitted through the appropriate channels, hence facilitating timely study approvals and authorizations. By maintaining ongoing regulatory compliance throughout the study, this service minimizes regulatory risks and delays, ensuring complete and accurate regulatory documentation, supporting successful inspections and audits.

HOW WILL THE SERVICE BE DELIVERED ? : The service is delivered by HUmani’s Clinical Research Unit through various meetings (face-to-face or remote) with the customer, and other relevant stakeholders where needed.

PROVIDER DESCRIPTION : HUmani CHU Charleroi-Chimay is a hospital network composed of five general and specialized hospitals and 8 polyclinics offering healthcare services in more than fifty medical and surgical specialties. Located in Belgium, at the heart of Europe, we are strongly committed to clinical research with the support of a dedicated Clinical Research Unit offering Clinical Research Organization (CRO)-like services.

TECHNICAL DETAILS : The service is performed in compliance with international guidelines for Good Clinical Practice (ICH-GCP E6 R3), the ISO 14155:2026 standard; EU regulations 2017/745 (MDR), and with the corresponding Belgian laws and Royal Decrees.

SERVICE CUSTOMIZATION : The service can be customized according to the SME’s specific needs, based on the availability of the clinical investigation plans (CIP, protocol). This service may be provided by HUmani either as part of its role as the full sponsor of your investigation study, or on an “à la carte” basis.

Service categories: 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
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Billing: per hour
Full Price 76–99 EUR
Reduced Price 54–70 EUR

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)
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