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Regulatory Compliance

Navigating the regulatory landscape is not just about ensuring compliance, it’s about steering innovation safely through the seas of change.

AxTalis supports clients in all regulatory matters throughout the lifecycle of a healthcare solution. By providing both strategic and operational support we help set the stage for current and future commercial success within a compliant framework. The close collaboration with our clients and with the AxTalis Access and Medical Teams allows a targeted intervention to ensure the optimal life cycle management with its obligations and opportunities.

At AxTalis, we empower you with a comprehensive suite of regulatory affairs services. From navigating the complexities of EMA Prime to achieving Orphan Drug Designations and securing Scientific Advice, we’re your ally.
Regulatory Affairs

  • RA strategy

  • EMA Prime, ODD, Scientific adivice, PIP

  • New MAA (Centralized, Mutual Recognition, Decentralized or National Procedures)

  • Regulatory life cycle management

  • CMC expertise

  • Medical device certification

We are your trusted partner in Pharmacovigilance & Medical Information, ensuring patient safety and compliance. We deliver expert monitoring, analysis, and reporting of adverse events, coupled with accurate and accessible medical information services.
Pharmacovigilance &
medical information

  • ICSR management

  • Local and global literature screening

  • Local Contact Person PV BeNeLux & QPPV (24/7)

  • Global PV set up

  • Risk management plan and Risk management activities (RMP & RMA)

  • Audit & Inspection readiness

  • Local and global medinfo support (24/7)

AxTalis champions BeNeLux legal roles and expertise, providing robust support in regulatory compliance and legal counsel. Our team is adept in navigating the intricate legal landscapes of Belgium, the Netherlands, and Luxembourg, ensuring your operations are in full alignment with local laws and regulations.
BeNeLux legal roles and expertise

  • Local Contact Person PV BeNeLux (24/7)

  • Responsible for information and publicity (RIP in BE)

  • Responsible person for GDP (RP)

  • Qualified Person (QP)

  • Legal representative health authorities

  • Local disclosure transfer of value (BeNeLux)

For more information or a chat contact me through wim.neckebroeck@axtalis.com
Wim Neckebroeck

Director Regulatory Affairs

Linkedin

Let’s have a chat.

We pride ourselves to have a personal relationship with our network of stakeholders, opinion leaders and clients, and we would love to get to know you as well. Feel free to reach out for a chat.

Contact us

Medical Affairs, Market Access and Regulatory Compliance

Arthur Vanlaethemstraat 1
9050 Gentbrugge
Belgium
BE0745.587.926

RPR Gent afdeling Gent
Supervising authority for pharmacovigilance: FAMHP
(ADR@fagg.be)

Contact us

M • info@axtalis.com

Contact us

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