EU & UK REGULATORY AFFAIRS
END-TO-END REGULATORY SUPPORT THROUGHOUT THE PRODUCT LIFECYCLE
PHA FARMED provides strategic and operational regulatory support for pharmaceutical, biotechnology and healthcare companies entering and operating in European markets.
Our senior experts support clients throughout the product lifecycle, from regulatory strategy and submissions to post-approval activities and ongoing compliance.
REGULATORY STRATEGY & SUBMISSIONS
Regulatory strategy and hands-on support for EU and UK market entry, product development and lifecycle management.
- Regulatory strategy and pathway assessment
- Marketing authorisation applications
- National, MRP, DCP and centralised procedures
- Variations, renewals and post-approval activities
- Regulatory authority interactions
REGULATORY DOCUMENTATION & LIFECYCLE MANAGEMENT
Preparation, review and coordination of regulatory documentation throughout development, submission and the post-approval lifecycle.
• CTD/eCTD documentation support
• Product information and labelling
• Variations and lifecycle documentation
• Gap assessments and dossier review
• Regulatory documentation coordination
REGULATORY PARTNER NETWORK
Access to experienced regulatory specialists and local expertise where additional country-specific support is required.
- EU and UK regulatory expertise
- Local regulatory intelligence
- Coordination with national experts
- Support for complex market-entry projects
- Flexible expertise tailored to each project
Need regulatory support for your European market?
Let’s discuss the regulatory strategy and expertise your project requires.