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ServiceUpdated on 17 August 2025

Regulatory Affairs Services

Jane Müller

Head Legal, Business Development representative at Luminance Health

Basel, Switzerland

About

The main Regulatory Affairs services areas include:

  1. Early development

    • Regulatory strategy

    • CMC strategy

    • Development plan

    • Due diligence

  2. Pre-registration activities

    • CTA/IND/ODD&PIP

    • Scientific advice

    • MAA strategy

    • Pre-submission meeting

  3. Registration activities

    • Full MAA/NDA support

    • Dossier preparation and submission

    • Liaison with authorities

    • Project management

  4. Post-approval support

    • Product launch

    • Lifecycle management

    • Regulatory compliance

    • Regulatory intelligence

Type

  • Consulting
  • Others

Applies to

  • Development stages and support fuctions - Clinical research and development
  • Development stages and support fuctions - Regulatory and compliance

Organisation

Luminance Health

Consultant

Basel, Switzerland

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