Regulatory Affairs
Marketing authorisation applications, lifecycle management, regulatory intelligence, strategy, gap analyses and agency interaction.
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Pharmaceutical compliance · Benelux & EU
Your pharmaceutical compliance partner in the BeNeLux
Expert, flexible support across Regulatory Affairs, Quality Assurance, Pharmacovigilance and Medical Affairs for Belgium, The Netherlands and Luxembourg
Regulatory strategyOperational supportLocal Benelux expertise
Our expertise
Compliance without unnecessary complexity
From strategy to execution, we strengthen your team where expertise, capacity and local knowledge matter.
Quality Assurance
QMS maintenance, distribution, administrative release, complaints, SOPs, change control, audits and inspections.
Learn morePharmacovigilance
Adverse event follow-up, local PV activities, training and support with product safety matters.
Learn moreMedical Affairs
Scientific and pharmaceutical enquiries, medical information and review of promotional materials.
Learn moreRA Consultancy
A trusted extension of your team
RA Consultancy supports pharmaceutical organisations with practical expertise, clear communication and an approach tailored to your product, timeline and organisation.
Flexible project-based or long-term support
Experience with local and European requirements
Direct contact with an experienced consultant
Benelux
Belgium · Netherlands · Luxembourg
From product to patient
Support throughout the product lifecycle
We assist with market access, lifecycle maintenance, quality systems, safety follow-up and scientific enquiries.
SectorsReady to discuss a compliance project or need?
Tell us where your team needs support. We will contact you personally.