Description
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IND/CTA Module Development (CTD 2.5, 2.7) – Regulatory Summaries
CTD Modules 2.5 (Clinical Overview) and 2.7 (Clinical Summary) are critical components of your regulatory submission that synthesize and interpret the entire clinical development program. These high-level summaries directly influence regulatory decision-making and require expert scientific writing with deep understanding of regulatory expectations.
Editverse provides comprehensive CTD Module 2.5 and 2.7 development services delivered by experienced regulatory medical writers who understand what health authorities need to see for efficient review and approval.
📋 Understanding CTD Module 2.5 and 2.7
| Module | Purpose | Typical Length |
|---|---|---|
| 2.5 Clinical Overview | High-level critical analysis of clinical data, benefit-risk assessment, proposed labeling justification | 30-80 pages |
| 2.7.1 Summary of Biopharmaceutics & PK | ADME, bioavailability, drug interactions, special populations PK | 50-150 pages |
| 2.7.2 Summary of Clinical Pharmacology | Pharmacodynamics, dose-response, PK/PD relationships | 30-100 pages |
| 2.7.3 Summary of Clinical Efficacy | Efficacy data synthesis across all studies, subgroup analyses | 100-300 pages |
| 2.7.4 Summary of Clinical Safety | Pooled safety analysis, ISS integration, risk characterization | 150-400 pages |
| 2.7.5 Literature References | Published literature supporting clinical sections | Variable |
| 2.7.6 Individual Study Synopses | Tabular synopses of all clinical studies | Variable |
📜 Regulatory Framework
| Guideline | Application |
|---|---|
| ICH M4E(R2) | CTD – Efficacy (defines 2.5 and 2.7 structure and content) |
| ICH E1 | Population Exposure – safety database requirements |
| ICH E9(R1) | Statistical Principles – estimands and analysis approaches |
| FDA NDA/BLA Guidance | US-specific requirements and expectations |
| EMA Guideline on SmPC | EU labeling requirements informing 2.5 content |
📊 Service Scope
Module 2.5 – Clinical Overview Development
- ✅ Product development rationale and therapeutic context
- ✅ Overview of biopharmaceutics and clinical pharmacology
- ✅ Clinical efficacy overview with key findings synthesis
- ✅ Clinical safety overview with risk characterization
- ✅ Benefit-risk assessment – the most critical section for regulatory decision-making
- ✅ Proposed indication and labeling justification
- ✅ Literature review integration
Module 2.7 – Clinical Summary Development
- ✅ 2.7.1 – Biopharmaceutics: absorption, bioavailability, formulation development
- ✅ 2.7.1 – PK: distribution, metabolism, excretion, drug interactions, special populations
- ✅ 2.7.2 – Mechanism of action, pharmacodynamic markers, dose selection rationale
- ✅ 2.7.3 – Efficacy by indication, dose-response, subgroups, supportive studies
- ✅ 2.7.4 – Exposure, adverse events, laboratory findings, vital signs, ECG, safety in special populations
- ✅ 2.7.5 – Literature references and synopses
- ✅ 2.7.6 – Tabular study synopses
⚙️ Development Workflow
| Phase | Activities | Timeline |
|---|---|---|
| 1. Planning | Kick-off, submission strategy alignment, document planning | Week 1-2 |
| 2. Data Integration | CSR review, ISS/ISE alignment, pooled data coordination | Week 2-4 |
| 3. Module 2.7 Writing | Draft all 2.7 subsections | Week 4-10 |
| 4. Module 2.5 Writing | Develop Clinical Overview and benefit-risk | Week 8-12 |
| 5. Internal Review | Medical, scientific, regulatory, QC review | Week 12-14 |
| 6. Sponsor Review | Client review cycles and comment resolution | Week 14-18 |
| 7. Finalization | Final QC, cross-referencing, eCTD formatting | Week 18-20 |
Standard Timeline: 16-20 weeks (full Module 2.5 + 2.7 package)
Individual Modules: Can be developed separately based on submission needs
📋 Service Options
| Package | Includes | Best For |
|---|---|---|
| Complete CTD Clinical Package | Module 2.5 + all 2.7 subsections | NDA/BLA/MAA submissions |
| Module 2.5 Only | Clinical Overview with benefit-risk | When 2.7 exists or is developed separately |
| Module 2.7 Only | All Clinical Summary sections | Data synthesis without overview |
| Individual Subsections | Specific 2.7.x sections | Filling gaps in existing submissions |
| IND/CTA Package | Abbreviated 2.5/2.7 for investigational applications | First-in-human and early development |
✨ Why Choose Editverse
| Feature | Benefit |
|---|---|
| Regulatory Strategy Alignment | Writers who understand how 2.5/2.7 support approval decisions |
| Benefit-Risk Expertise | Compelling benefit-risk narratives that address regulatory concerns |
| Cross-Document Consistency | Perfect alignment with ISS/ISE and CSRs |
| Global Experience | FDA, EMA, PMDA, Health Canada submission experience |
| Labeling Support | 2.5 content designed to support USPI/SmPC claims |
📦 Deliverables
- ✅ Module 2.5 Clinical Overview – Complete with benefit-risk assessment
- ✅ Module 2.7.1-2.7.6 – All clinical summary subsections
- ✅ Supporting Tables and Figures – Integrated summary tables
- ✅ Cross-Reference Maps – Links to Module 5 source documents
- ✅ eCTD-Ready Formatting – Hyperlinked, bookmarked, submission-ready
📞 Get Started
Contact us to discuss your submission timeline and scope:
📧 Email: co*****@*******se.com
🌐 Web: editverse.com
Pricing provided in your local currency. Scope-based quotes tailored to your development program complexity.
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