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.

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  • 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

  • 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)

  • 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)

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
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