Medical Writing & Regulatory Services
Our comprehensive suite of services is meticulously tailored to your specific clinical and regulatory needs. Each document we produce is accurate, compliant, and strategically positioned to support your clinical objectives.
Our expertly crafted Clinical Study Reports adhere to ICH E3 guidelines, effectively communicating your study results to regulatory authorities.
- Full regulatory compliance with ICH E3 standards
- Clear, detailed analysis ensuring regulatory acceptance
- Strategic presentation of data to support product value
- Integration of study results into broader regulatory narrative
Clear, compliant, and insightful patient safety narratives for regulatory submissions, inspections, and internal safety reviews.
- Expert medical writers with regulatory experience
- End-to-end support for large and small projects
- Modern, scalable, and quality-focused approach
Expert preparation of DSURs, PSURs, and other pharmacovigilance safety reports to ensure regulatory compliance and patient safety.
- DSUR & PSUR preparation
- Aggregate safety data analysis
- Regulatory strategy & support
Thorough, independent quality checks for all regulatory and clinical documents to ensure accuracy, consistency, and compliance.
- Independent, expert review for unbiased quality assurance
- Comprehensive, audit-ready QC documentation
- Collaborative approach with your writing and regulatory teams
Expert preparation of CTD summaries and overviews for global regulatory submissions, ensuring clarity, compliance, and strategic positioning.
- High-impact Module 2 summaries
- Strategic overviews for product value
- Global compliance with FDA, EMA, PMDA
Clear, compliant, and actionable SOPs to ensure quality, consistency, and regulatory adherence across your clinical and operational processes.
- Deep expertise in clinical, regulatory, and operational SOPs
- Collaborative approach for tailored solutions
- Clear, actionable, and audit-ready documentation
Comprehensive documentation for regulatory submissions, including clinical overviews, summaries, and briefing documents.
- Clinical overviews and summaries (Module 2.5, 2.7)
- Briefing documents for regulatory meetings
- Responses to regulatory authority questions
- Integrated summaries of efficacy and safety
Strategic protocol development that balances scientific, regulatory, and operational considerations for successful clinical trials.
- Phase I-IV clinical trial protocols
- Protocol amendments and administrative changes
- Collaborative design with key stakeholders
- Informed consent forms and participant documentation
Comprehensive summaries of relevant clinical and nonclinical data to support investigator understanding and patient safety.
- ICH GCP-compliant format and content
- Clear presentation of safety information
- Regular updates as new data emerges
- Strategic integration into clinical development
Specialized medical writing services for a wide range of clinical and regulatory documents beyond our core offerings.
- Custom medical writing projects
- Support for unique or complex documents
- Flexible solutions for evolving needs
Our Process
A streamlined approach to delivering high-quality documentation on time.
Initial Consultation
We discuss your needs, timeline, and specific requirements to understand the scope of your project.
Team Assembly
We assign specialists with relevant therapeutic and document expertise to your project.
Content Development
Our team creates high-quality documentation following regulatory guidelines and best practices.
Review & Refinement
Multiple quality control reviews ensure accuracy, compliance, and alignment with your goals.
Finalization & Delivery
Final documents are delivered on time with full support through submission and beyond.
Why Choose EloquiMed
Partner with a team that combines scientific expertise with regulatory insight.
PhD/MD-level writers with therapeutic area expertise
Former regulatory agency professionals on staff
Extensive experience across document types
Rigorous quality control processes
On-time delivery track record
Global regulatory knowledge and perspective
What Our Clients Say
Trusted by leading pharmaceutical and biotech companies.
EloquiMed's meticulous approach to our Clinical Study Reports was instrumental in our recent successful submission. Their team's expertise shone through.
Head of Clinical DevelopmentLeading Pharma Innovator
Our Capabilities
A comprehensive range of medical writing and regulatory services.
| Service Area | Clinical Documents | Regulatory Submissions | Safety Reporting | Scientific Publications |
|---|---|---|---|---|
| Early Phase | ||||
| Phase II-III | ||||
| Marketing Authorization | ||||
| Post-Marketing | ||||
| Medical Affairs |
Engagement Models
Flexible options to meet your specific needs and preferences.
Project-Based
Full-service documentation development for specific projects with defined deliverables.
- Fixed budget for defined deliverables
- Clear timelines and milestones
- Comprehensive project management
- Ideal for discrete documentation needs
Functional Service Provider (FSP)
Dedicated team resources for ongoing medical writing and regulatory support across multiple projects.
- Dedicated team for consistent support
- Resource flexibility based on demand
- Unified processes and standards
- Ideal for ongoing documentation needs
Strategic Consulting
Expert guidance on regulatory strategy, documentation planning, and submission optimization.
- Expert regulatory advice
- Documentation strategic planning
- Agency meeting preparation
- Ideal for strategic planning phases
Ready to elevate your medical documentation?
Contact us today to discuss how our services can support your specific needs.