Services
Valerie offers a variety of high-end services.
Valérie delivers a suite of premium services designed to meet your unique business challenges. With her expertise and experience, she crafts solutions that drive transformation. Reach out to Valérie today to unlock your business’s full potential.
Regulatory affairs
Valérie provides comprehensive Regulatory Affairs consultancy, specialising in:
- Pharmaceutical and Medical Device Life Cycle Management
- Artwork Review and Approval across multiple sectors
- Advertising Claims Verification for Food Supplements and Cosmetics
- Liaison with Regulatory Authorities, Notified bodies and Stakeholders
- Strategic Regulatory Guidance
Publicity
Valérie delivers expert publicity services, specialising in
- Serving as a Qualified Person for Information and Publicity (RIP), a legal requirement for Marketing Authorisation Holders with products on Belgium market
- Ensuring promotional materials meet EU and local legislative standards
- Medical Sales Representative Training
Valérie has been officially approved by Belgium’s Ministry of Public Health as a Responsible Person for Information and Publicity (RIP nr 948).
Quality Assurance
Valérie offers end-to-end Quality Assurance solutions, including:
- Quality Management System Implementation for Pharmaceutical Distribution, compliant with Good Distribution Practices (GDP)
- Routine Operations Management: batch releases, returns, quality complaints, CAPA, deviations, and training
- Audit and Inspection Preparedness
- Role as GDP Responsible Person
- ISO 13485-Certified Quality Management for Medical Devices
(Pharmaco)vigilance
Valérie provides specialised (Pharmaco)Vigilance services, encompassing:
- Role as EU Qualified Person for PharmacoVigilance
- Local Contact Person for Pharmacovigilance in Belgium
- Adverse Event Monitoring and Reporting
- EU Individual Case Safety Reports via EudraVigilance
- Medicinal Product Data Submission to XEVMPD
- Reconciliation and Literature Screening
- Customised (Pharmaco)Vigilance Training
- Regulatory Communication and Compliance
- Vigilance Quality System Management, aligned with Good Pharmacovigilance Practices (GVP)
Valérie has successfully completed the EudraVigilance and the eXtended EudraVigilance Medicinal Product Dictionary (XEVMPD) knowledge evaluation.
Other
Leveraging an extensive network of skilled freelancers, Valérie offers flexible solutions tailored to your specific needs. Committed to excellence, she goes the extra mile to find innovative solutions that deliver results.
Valérie also specialises in:
- Pricing & Reimbursement Strategies
- Strategic Leadership Roles
- Management Consultancy