Regulatory Compliance

Jan 23, 2023
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Many people working in Pharmaceutical or Medtech companies ask us what kind of a consulting agency AxTalis is nowadays.  Therefore, we are keen to inform you what you can expect working with us.

AxTalis has evolved towards a fully integrated Consulting Agency focussing on 3 strategic pillars: Market Access, Medical Affairs & Regulatory Compliance. AxtTalis has operational offices with dedicated staff in Belgium/Luxembourg and the Netherlands. 

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AxTalis' staff is selected based on educational background (Medical Doctor, Pharmacist, Biomedical Sciences, Chemistry) and acquired expertise in different domains.

Depending on the project you will be working with people having specific expertise in Epidemiology, Health economics & Data Analytics, Market Access Stratregy, Medical Writing, Medical affairs (incl. RIP), Medical Information, Regulatory Affairs and Pharmacovigilance.

In this post we want to focus on our Regulatory Compliance department led by Wim Neckebroeck. 

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Wim has a track record in both local and international Regulatory Affairs activities and has led major outsourcing projects in RA/PV across Europe.

Besides being an expert on life cycle management activities and pharmacovigilance in BeNeLux Wim is also passionate about the local Belgian RIP role which he has held for multiple pharma companies.

His team can deliver services in selected areas (see below) or can, if necessary, deliver the full set of services linked to Regulatory affairs and Pharmacovigilance. Companies can contract our services on an insourcing or outsourcing basis. 

The Regulatory Compliance Department consists of two main pillars :

Regulatory Affairs

  • Initial (marketing authorisation) applications and line extensions for medicinal products (CP, MRP/DCP, NP) and medical devices

  • Marketing authorization transfer applications

  • Variations and notifications

  • Renewals and Withdrawals

  • OTC switch

  • Artwork/linguistic review and approval

  • Product information and mock ups

  • Clinical Trial Applications (CTA)

  • Certificate of Pharmaceutical Product (CPP) applications

  • Medical Need and Compassionate Use programs

  • Direct Healthcare Professional Communications (DHPC) support

  • Regulatory Intelligence and Strategy

Pharmacovigilance

  • Full-time (24/7) service of a local qualified pharmacovigilance person and/or EU QPPV

  • Local and Global literature monitoring

  • Adverse Event Management and expedited reporting to EudraVigilance

  • Implementation and maintenance of PV system. Creation of Pharmacovigilance System Master File (PSMF), Safety Data Exchange Agreement (SDEA), Standard Operating Procedures (SOP)

  • Risk Management Plan (RMP) and Risk Minimisation Measures (RMM)

  • Signal Management & EudraVigilance data analysis system (EVDAS) database

  • Periodic Safety Update Report (PSUR)

  • Art. 57 database: eXtended EudraVigilance Medicinal Product Dictionary (XEVMPD)

For all your projects in Regulatory Affairs and Pharmacovigilance, please contact Wim via wim.neckebroeck@axtalis.com. He will be happy to build the right solution for your project!