Key Deliverables
Comprehensive support tailored to your specific regulatory needs.
EMA Marketing Authorization (MAA)
Navigate the centralized procedure for European approval, including PIPS, scientific advice, and dossier preparation.
Health Canada Submissions
Expert support for NDS (New Drug Submission) and SNDS filings, ensuring compliance with Canadian specific requirements.
PMDA (Japan) Consultations
Strategic guidance for entering the Japanese market, including consultation management and bridging study strategies.
Rest of World (ROW) Strategy
Efficient rollout strategies for emerging markets in Asia, Latin America, and the MENA region.
Multi-Regional Clinical Trials
Alignment of clinical development plans to satisfy requirements of multiple global health authorities simultaneously.
Our Approach
A proven methodology designed to minimize risk and maximize speed to market.
Global Assessment
We evaluate your product's potential in key global markets and identify regional regulatory requirements.
Harmonization Strategy
We design a core dossier approach to maximize content reuse across regions while addressing specific local nuances.
Local Representation
Through our network of local experts, we provide in-country representation and language support where required.
Lifecycle Coordination
We manage the complex choreography of global submissions and approvals to optimize your product's launch sequence.
Ready to Accelerate Your Regulatory Success?
Contact us today to discuss your specific needs and how we can support your goals.