Description
NDA/MAA Integrated Summaries (ISS/ISE) – Complete Regulatory Documentation Service
The Integrated Summary of Safety (ISS) and Integrated Summary of Efficacy (ISE) are critical components of New Drug Application (NDA) and Marketing Authorization Application (MAA) submissions. These comprehensive pooled analyses synthesize data across your entire clinical development program, providing regulatory authorities with the complete safety and efficacy picture needed for marketing authorization decisions.
Editverse provides end-to-end ISS/ISE development services from experienced regulatory medical writers who have contributed to successful NDA and MAA approvals across multiple therapeutic areas including oncology, cardiovascular, CNS, immunology, and rare diseases.
Service Overview
| Component | Description | Typical Length |
|---|---|---|
| ISS (Integrated Summary of Safety) | Pooled safety database analysis including exposure, adverse events, laboratory abnormalities, vital signs, ECG findings, deaths, and serious adverse events across all studies | 200-500+ pages |
| ISE (Integrated Summary of Efficacy) | Pooled efficacy analyses including primary/secondary endpoints, responder analyses, subgroup analyses, and benefit-risk assessment | 150-400+ pages |
What’s Included in This Service
Phase 1: Project Planning & Analysis Framework
- Kick-off meeting with sponsor clinical/regulatory team
- Review of clinical development program and study reports
- Integrated analysis plan development
- Pooled dataset specification and validation
- Statistical analysis plan (SAP) coordination
- Data poolability assessment
Phase 2: ISS Development
- Extent of exposure analysis (ICH E1 compliance)
- Adverse events analysis (common AEs, severity, causality)
- Deaths, SAEs, and discontinuations analysis
- Laboratory parameters evaluation
- Vital signs and ECG analysis
- Special populations safety (elderly, hepatic/renal impairment)
- Drug interaction safety data
- Safety subgroup analyses
- Long-term safety data integration
Phase 3: ISE Development
- Primary efficacy endpoint pooled analysis
- Secondary endpoint analyses
- Responder rate analyses
- Time-to-event analyses (if applicable)
- Dose-response relationships
- Subgroup efficacy analyses (age, sex, race, disease severity)
- Supportive/exploratory efficacy analyses
- Persistence of effect analyses
Phase 4: Benefit-Risk & Integration
- Comprehensive benefit-risk assessment
- Comparison with standard of care
- Cross-referencing with CTD Module 2.5 and 2.7
- Regulatory query response preparation
Development Workflow
| Stage | Activities | Duration | Deliverable |
|---|---|---|---|
| 1. Initiation | Document review, kick-off, analysis planning | 1-2 weeks | Integrated Analysis Plan |
| 2. Data Integration | Pooled dataset validation, TFL shell development | 2-4 weeks | TFL Shells, Pooled Dataset Specs |
| 3. Draft Development | ISS and ISE writing, table/figure integration | 6-10 weeks | Draft ISS + ISE |
| 4. Internal Review | Medical, scientific, and QC review | 2-3 weeks | Review-Ready Documents |
| 5. Sponsor Review | Client feedback incorporation | 2-4 weeks | Revised ISS + ISE |
| 6. Finalization | Final QC, publishing, regulatory formatting | 1-2 weeks | Final ISS + ISE (PDF/Word) |
Total Timeline: 12-20 weeks (complexity dependent)
Regulatory Framework Compliance
| Guideline | Application |
|---|---|
| ICH E1 | Extent of Population Exposure to Assess Clinical Safety |
| ICH E9 | Statistical Principles for Clinical Trials |
| ICH M4E | CTD – Efficacy Module Organization |
| ICH M4S | CTD – Safety Module Organization |
| FDA 21 CFR 314 | NDA submission requirements |
| EMA MAA Guidelines | Marketing Authorization Application requirements |
Why Choose Editverse for ISS/ISE Development
| Feature | Editverse Advantage |
|---|---|
| Experience | Writers with 10+ years in regulatory submissions, contributing to FDA/EMA-approved products |
| End-to-End Service | From analysis planning through final publishing – no handoffs between vendors |
| Statistical Integration | In-house biostatisticians ensure seamless TFL integration and analysis support |
| Regulatory Intelligence | Up-to-date knowledge of FDA/EMA expectations and recent review trends |
| Quality Assurance | Multi-level QC process including medical, scientific, and regulatory review |
| Flexible Engagement | Fixed-price project or time & materials based on your needs |
| Post-Submission Support | Agency query responses and amendment support included |
Therapeutic Areas Covered
Our regulatory writing team has ISS/ISE experience across:
- Oncology – solid tumors, hematologic malignancies, immuno-oncology
- Cardiovascular – heart failure, hypertension, anticoagulation
- CNS – neurology, psychiatry, pain management
- Infectious Disease – antibiotics, antivirals, vaccines
- Rare Diseases – orphan drug development experience
- Immunology/Inflammation – autoimmune conditions, dermatology
- Metabolic/Endocrine – diabetes, obesity, lipid disorders
Deliverables
- Integrated Summary of Safety (ISS) – Final document in Word and PDF
- Integrated Summary of Efficacy (ISE) – Final document in Word and PDF
- Supporting Tables, Figures, and Listings (TFLs)
- Integrated Analysis Plan
- Annotated templates for eCTD publishing
- Response document templates for agency queries
Pricing
| Package | Scope | Price |
|---|---|---|
| ISS + ISE Complete | Both documents, full program integration | $75,000 |
| ISS Only | Integrated Summary of Safety | Contact for quote |
| ISE Only | Integrated Summary of Efficacy | Contact for quote |
Final pricing based on number of studies, complexity, and timeline requirements. Volume discounts available for full NDA/MAA programs.
Get Started
Contact our regulatory team for a detailed scope assessment and proposal:
Email: co*****@*******se.com
Web: editverse.com
Confidentiality assured. NDA available upon request.
