Regulatory Affairs

Luminance Health’s team of regulatory experts provides strategic advice and hands-on operational support throughout the whole lifecycle of drugs and advanced therapy medicinal products (ATMPs), from early development to registration, launch and post-marketing activities.

We guide our clients through the regulatory process, from clinical trial applications to scientific advice, end of phase 2, MAA/NDA/BLA preparation and submission as well as maintenance and post-approval activities. Our team meticulously ensures that your product and dossiers meet the regulatory requirements.

Early development

  • Regulatory strategy

  • CMC strategy

  • Development plan

  • Due diligence

Pre-registration activities

  • CTA/IND/ODD & PIP

  • Scientific advice

  • MAA strategy

  • Pre-submission meeting

Registration activities

  • Full MAA/NDA support

  • Dossier preparation and submission

  • Liaison with authorities

  • Project management

Post-approval support

  • Product launch

  • Lifecycle management

  • Regulatory compliance

  • Regulatory intelligence