Overview
Beyond the ICH regions, the world offers vast opportunities. We help you develop a rollout strategy for emerging markets in Asia, Latin America, and the Middle East. We leverage Certificate of Pharmaceutical Product (CPP) strategies to minimize local requirements.
Key Features
Regional prioritization strategy
CPP management
Local partner identification
Dossier customization
Our Process
1
Prioritization
Ranking markets based on potential and ease of entry.
2
Planning
Sequencing submissions to optimize CPP availability.
3
Execution
Managing local filings through affiliates or partners.
Project Complete & Deliverables Provided
Frequently Asked Questions
A CPP is a WHO-format document issued by a regulatory authority (like FDA or EMA) certifying that a drug product is authorized for sale in that country. Over 80 countries require CPPs as part of their registration dossiers. It's essentially proof that a trusted agency has already reviewed your product's quality, safety, and efficacy—allowing local agencies to rely on that assessment.
Why Choose Us
- Maximized global revenue
- Efficient use of core dossier
- Risk diversification
- Patient access worldwide
Get More Details
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Contact our team to discuss your specific needs for Rest of World (ROW) Strategy.
Schedule ConsultationWhat Our Clients Say
"We had 40 markets to cover with limited resources. Adelphi prioritized the top 15 by ROI, sequenced submissions around our FDA CPP availability, and identified local partners in each market. We achieved 90% market coverage within 18 months of our first approval."
Maria Santos
Director International Regulatory
Mid-Size Pharma
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