Global Submission Strategy for Novel Therapeutic
Developing and executing a coordinated multi-regional submission approach that accelerated global market access for a breakthrough therapy.
Case Study Overview
EloquiMed designed and implemented a comprehensive global submission strategy that enabled rapid regulatory approvals across major markets while maximizing operational efficiency.
Client
Mid-size Biopharmaceutical Company
Therapeutic Area
Immunology / Autoimmune Disease
Document Type
Global Regulatory Submission Strategy
Result
Accelerated approvals across 6 major markets with unified dossier approach
The Challenge
Developing an effective global submission strategy for a client with limited international regulatory experience and resource constraints.
Divergent Regulatory Requirements
Navigating significantly different submission requirements, review processes, and data presentation expectations across US FDA, EMA, PMDA, Health Canada, TGA, and NMPA.
Complex Clinical Program
Integrating data from multiple clinical trials with evolving protocols, including a pivotal study with regional differences in design and implementation across global sites.
Resource Constraints
Developing and executing a global strategy with a lean regulatory team and limited prior experience in multiple regional submissions, particularly for Asian markets.
Aggressive Timelines
Meeting an ambitious 18-month timeline for submissions across all six target markets to achieve commercial objectives and maintain competitive advantage.
Key Strategic Challenges
Our Strategic Solution
EloquiMed implemented a comprehensive, modular approach to global submissions that maximized efficiency while addressing regional requirements.
Core Dossier Development
Created a scientifically robust core dossier with modular components that could be efficiently adapted for different regulatory authorities while maintaining consistency.
Strategic Submission Sequencing
Developed an optimized submission sequence that leveraged early regulatory interactions and approvals to facilitate subsequent submissions across regions.
Regional Advisory Partnerships
Established strategic partnerships with regional regulatory experts to provide market-specific insights and optimize submissions for local requirements.
Integrated Project Management
Implemented a centralized project management system with specialized regulatory tracking tools to coordinate parallel submission workstreams efficiently.
Strategic Submission Timeline
FDA Submission & Pre-Approval Inspections
EMA & Health Canada Submissions
PMDA & TGA Submissions
NMPA Submission
Results and Impact
Our strategic approach delivered exceptional outcomes that exceeded the client's expectations and business objectives.
Accelerated Approvals
Secured approvals in all six target markets within 21 months, beating the original timeline by 3 months and accelerating market access.
First-Cycle Approvals
Achieved first-cycle approval in 5 of 6 markets, with only minor clarifications required during the review process and no major deficiency letters.
Resource Optimization
Reduced document preparation resources by approximately 35% through the modular dossier approach and strategic reuse of content across submissions.
Strategic Value Creation
Beyond achieving the immediate goal of global approvals, our submission strategy created lasting value for the client. The modular approach and project management infrastructure established during this project became the organization's global template for subsequent submissions. Additionally, the regional partnerships forged during this initiative continue to provide strategic advantages for the client's expanding global portfolio.
Key Documentation Delivered
Our comprehensive solution included development of the following critical components:
Global Submission Strategy
Core Clinical Overview
Integrated Summaries
Regional Adaptations
Regulatory Meeting Briefings
Response Strategies
Project Management Tools
Training Materials
Process Timeline
Our systematic approach to global submission strategy:
Phase 1: Strategy Development
- • Comprehensive assessment of product profile and clinical data
- • Regulatory landscape analysis across target markets
- • Gap analysis and requirements mapping
- • Development of global submission strategy and timeline
Phase 2: Core Dossier Development
- • Creation of modular core submission documents
- • Development of integrated efficacy and safety analyses
- • Scientific advice meetings with key agencies
- • Implementation of feedback into core documentation
Phase 3: Regional Submissions
- • Sequential preparation and submission of regional dossiers
- • Adaptation of core content for regional requirements
- • Coordination of translations and local regulatory partners
- • Management of concurrent review processes
Phase 4: Regulatory Response Management
- • Coordinated management of regulatory review questions
- • Development of harmonized response strategies
- • Cross-regional knowledge sharing
- • Preparation for approval and post-approval commitments
Related Case Studies
Explore more examples of our expertise in regulatory strategy and submissions:
Successful FDA BLA Submission in Oncology
First-cycle approval for a novel cancer therapy through expert documentation.
Global Risk Management Strategy
Harmonized approach to risk management that succeeded across multiple regulatory agencies.
Expedited CSR Development
Rapid development of high-quality clinical study reports to meet regulatory deadlines.