Fostering meaningful
growth in Life Science
Regulatory Affairs • Quality Assurance • Pharmacovigilance
Medical Communication • Market Access • Public Affairs
Compliance • Project Management
Regulatory Affairs
Luminance Health’s team of regulatory experts provide 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 help 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 for drug development.
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