NDA Services
Your partner for successful NDA submissions.
From pre-IND strategy to post approval support, GLOBAL provides the expertise, structure, and efficiency needed to move your small molecule program forward with confidence.
What is an NDA?
An NDA (New Drug Application) is the formal proposal submitted to the FDA (U.S. Food and Drug Administration) requesting approval to market a new pharmaceutical for sale and distribution in the United States. It brings together all safety, efficacy, and quality data across nonclinical, clinical, and CMC disciplines. It’s the final step in the drug development process—and one of the most complex regulatory hurdles pharma companies face. A well-executed NDA is critical for achieving approval and reaching patients on time.
Why Choose GLOBAL for NDA Services?
- End-to-end expertise: Our experienced writers and consultants deliver across Modules 1–5, with particular strength in CMC Module 3 and clinical overviews.
- Efficient authoring and QC: eCTD ready templates, strict QC, and publishing coordination ensure clean, submission ready deliverables.
- Flexible engagement models: Whether project based or through a Functional Service Provider (FSP) model, we scale with your pipeline.
- Global regulatory insight: Alignment with FDA expectations and ICH guidance reduces risk of information requests and review delays.
Our NDA Services
Strategy & Planning
- IND to NDA transition planning
- Pre-NDA meeting support and briefing package authoring
- Labeling strategy and Target Product Profile (TPP) development
Authoring & Compilation
- Module 2 summaries and overviews
- CMC Module 3 (Quality/Pharmaceutical) sections
- Administrative forms and SPL labeling
Submission & Review Support
- eCTD QC and publishing coordination
- Information Request (IR) and Review Letter responses
- Advisory Committee preparation support
Post Approval
- Amendments and annual reports
- Labeling updates and lifecycle management
Proven Approach
1
Readiness Assessment
Identify document gaps, risks, and timelines.
2
Structured Authoring
Prioritized drafting with SME input and QC.
3
Integration & Consistency
Cross module checks, version control, and audit trails.
4
Submission Preparation
eCTD handoff, reviewer guides, and quality checks.
5
Regulatory Interaction
Support through FDA review and post approval commitments.
Frequently Asked Questions
CMC alignment. Incomplete or inconsistent narratives around process validation, stability, and control strategy can delay approval. GLOBAL mitigates these risks early.
NDAs apply to small molecule drugs. BLAs cover biologics, while ANDAs are for generics.
Yes, including literature bridges, integrated summaries, and streamlined development strategies.