Proven Success Stories
Explore real-world examples illustrating our capability to navigate complex regulatory environments, achieving optimal outcomes for our clients.
Featured Case Study
Successful FDA BLA Submission in Oncology
How we helped a mid-size biotech company achieve first-cycle approval for their novel cancer therapy.
Therapeutic Area
Oncology
Document Type
Submission
Challenge
Extensive data from complex trial designs
Outcome
First-cycle approval without advisory committee
All Case Studies
Filter by therapeutic area or document type to find relevant success stories.
Immunology
Immunotherapy Investigator Brochure
Development of a comprehensive Investigator Brochure for a first-in-class immunotherapy entering Phase II trials.
Challenge:Complex pharmacological data communication
Solution:Clear, compliant IB aligning with EMA requirements
Outcome:Smooth progression into Phase II with positive feedback
Rare disease
Orphan Drug Designation Support
Strategic documentation support for a biotech startup seeking orphan drug designation for a rare neurological disorder treatment.
Challenge:Limited natural history data for ultra-rare condition
Solution:Comprehensive literature review and robust scientific rationale
Outcome:Successful designation with first submission
Neurology
Neurology CSR for Phase III Study
Preparation of a complex Phase III Clinical Study Report for a neurodegenerative disease treatment with multiple endpoints.
Challenge:Complex endpoint analysis and tight timeframe
Solution:Clear data presentation with strategic narrative
Outcome:Rapid regulatory review with minimal queries
Oncology
Regulatory Submission Strategy Overhaul
Complete restructuring of a pharmaceutical company's regulatory document preparation and submission process.
Challenge:Inconsistent quality and frequent regulatory delays
Solution:Standardized templates and streamlined processes
Outcome:50% reduction in document preparation time
Oncology
Adaptive Protocol Design
Development of an adaptive protocol for a complex oncology trial with multiple treatment arms.
Challenge:Complex statistical considerations and emerging biomarkers
Solution:Transparent decision frameworks and clear stopping rules
Outcome:Efficient trial advancement with robust interim analyses
Cardiovascular
Risk Management Plan Development
Creation of a comprehensive EU Risk Management Plan (RMP) for a product with significant safety concerns.
Challenge:Complex safety profile requiring special monitoring
Solution:Strategic risk minimization measures
Outcome:EMA approval with all proposed monitoring accepted
Neurology
DSUR for Neurological Disease Treatment
Preparation of a Development Safety Update Report for a novel neurological disease treatment in Phase II development.
Challenge:Emerging safety signals requiring expert interpretation
Solution:Thorough safety data analysis with clinical context
Outcome:Continued development with appropriate monitoring adjustments
Infectious disease
Global Risk Management Strategy
Development of an integrated global risk management strategy spanning EU RMP, US REMS, and additional regional requirements.
Challenge:Divergent regulatory requirements across key markets
Solution:Core strategy with market-specific adaptations
Outcome:Simultaneous approval in multiple regions
Oncology
Oncology PBRER with Complex Safety Profile
Development of a Periodic Benefit-Risk Evaluation Report for an established oncology product with emerging safety concerns.
Challenge:Benefit-risk assessment with new safety signals
Solution:Robust benefit analysis contextualizing safety findings
Outcome:Maintained positive benefit-risk balance with minimal labeling changes
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