Regulatory Submissions
Expert development of compelling regulatory documentation to support successful global submissions and accelerate your product approval.
Comprehensive Regulatory Documentation Expertise
The quality of your regulatory documentation directly impacts approval timelines, labeling outcomes, and market success. EloquiMed specializes in developing scientifically robust, strategically aligned, and compliant regulatory documentation for submissions worldwide.
Our experienced regulatory writers work closely with your teams to create submission-ready documents that:
- Present your data in the most compelling and scientifically sound manner
- Align with your overall regulatory strategy and value proposition
- Address potential regulatory concerns proactively
- Comply with regional submission requirements and guidance documents
- Support positive benefit-risk assessments and favorable labeling outcomes
- Streamline the review process and minimize regulatory questions
New Applications
NDAs, BLAs, MAAs, and other initial marketing applications
Global Submissions
FDA, EMA, PMDA, Health Canada, and other health authorities
Development Milestones
INDs, CTAs, scientific advice, pre-NDA/BLA meetings
Lifecycle Management
Supplemental applications, variations, and extensions
Our Regulatory Documentation Services
Comprehensive solutions for all aspects of your regulatory documentation needs
Concise, strategic overviews that frame your product's profile and set the stage for regulatory review.
Compelling benefit-risk evaluations and strategic clinical narratives that support positive regulatory decisions.
Comprehensive yet focused summaries of biopharmaceutics, clinical pharmacology, efficacy, and safety data.
Region-specific documents including application forms, prescribing information, and risk management plans.
Clear communication of complex CMC information focusing on critical quality attributes and control strategies.
Strategic integration of pharmacology, pharmacokinetics, and toxicology data to support clinical development.
Our Approach to Regulatory Documentation
A strategic methodology ensuring submission success through scientific excellence and regulatory insight
Thorough assessment of data package, regulatory requirements, and program objectives to develop a strategic documentation plan.
Development of unified scientific narratives and benefit-risk frameworks that align with regulatory expectations.
Creation of high-quality documentation by specialized writers with therapeutic and regulatory expertise.
Rigorous review process ensuring scientific accuracy, regulatory compliance, and messaging consistency across all documents.
Global Regulatory Expertise
EloquiMed provides comprehensive support for submissions to major health authorities worldwide, with strategic understanding of regional requirements.
US FDA
Deep expertise in FDA submission requirements, guidance documents, and review practices across divisions.
European EMA
Comprehensive knowledge of centralized procedure requirements and expectations of EU rapporteurs.
Japan PMDA
Specialized expertise in Japan's unique documentation requirements and review considerations.
Other Global Markets
Experience with Health Canada, TGA, NMPA, and other health authorities' specific documentation needs.
Case Study: Global Submission Success
How EloquiMed supported a simultaneous global submission strategy for a novel therapy
Challenge
A mid-size pharmaceutical company was preparing its first global registration for a novel therapy in a highly competitive indication. The client needed to submit to FDA, EMA, and PMDA within a three-month window, with complex data from multiple pivotal trials showing modest but consistent efficacy and a nuanced safety profile.
Solution
Unified Submission Strategy
Developed a core global documentation package with strategic region-specific customizations.
Benefit-Risk Narrative
Created a compelling yet transparent benefit-risk framework that anticipated and addressed potential regulatory concerns.
Integrated Analysis Strategy
Developed novel integrated analyses that strengthened the overall efficacy and safety profile across studies.
Parallel Development
Implemented a parallel documentation development process with specialized teams for each region.
Results
3
Regions submitted within target timeline
80%
Reduction in regulatory queries
First-cycle
Approval in all major markets
40+
High-quality documents delivered
EloquiMed transformed our complex data into a clear, compelling submission strategy that resonated with regulators. Their strategic approach and attention to regional nuances were critical to our global approval success.
Benefits of Our Regulatory Documentation Services
Working with EloquiMed's regulatory documentation specialists provides numerous advantages for your submission success.
- Increased likelihood of first-cycle approval through strategic data presentation
- Optimal labeling outcomes supporting commercial objectives
- Significant time and resource savings for your internal teams
- Consistent messaging and quality across all submission components
- Reduced health authority questions through proactive issue identification and resolution
- Experienced perspective on regulatory expectations and precedents
- Flexible capacity to meet aggressive submission timelines
First-cycle approval rate for submissions we've supported
Regulatory documents authored in the past 3 years
Global markets supported with regulatory documentation
NDAs/BLAs/MAAs successfully supported to approval
Our Regulatory Documentation Team
Experienced specialists with deep regulatory knowledge and therapeutic expertise
Former FDA reviewer with 15+ years of experience in clinical and regulatory documentation across multiple therapeutic areas.
Regulatory affairs specialist with expertise in global submission strategies and region-specific documentation requirements.
Specialized in quality and CMC documentation with extensive experience in biologics and complex drug products.
Frequently Asked Questions
Common questions about our regulatory submission services
Ideally, 6-12 months before planned submission to allow for strategic planning, gap assessment, and document development. However, we can accommodate urgent timelines with our flexible resourcing model.
We focus on document authoring and can partner with your publishing team or our trusted eCTD publishing partners to ensure seamless submission preparation.
Yes, we provide comprehensive support for all post-submission activities including preparation of responses to information requests, meeting materials, and labeling negotiations.
We conduct thorough data assessments to identify potential regulatory concerns and develop strategic approaches to data presentation, contextual analysis, and benefit-risk characterization.
Ready to discuss your regulatory submission needs?
Contact EloquiMed today to learn how our regulatory documentation expertise can support your product approval success.