comprehensive IND regulatory consulting and submission services.
Investigational New Drug (IND) Application
At GLOBAL, we provide end-to-end IND submission support, from strategic planning and content authoring to final publishing. Our experienced regulatory team combines deep scientific knowledge with regulatory expertise to develop INDs that are accurate, compliant, and FDA-ready at every stage of the process.
Ways of Working
By partnering with GLOBAL, you can choose how best to utilize our expertise.
Review:
Have you already completed your IND and want expert eyes to review before you submit? Our team can dig in and ensure you have all you need for a successful submission.
Write:
If you need a team to write the IND from the beginning, our subject matter experts can deliver. Simply provide your data, and our team will do the rest.
Co-create:
Do you want to be involved in the process and lean on our team of experts to do the heavy lifting? We can work together to co-create the IND submission.
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IND Timeline
1
Preclinical Phase
- In vitro and in vivo animal studies
- Pharmacology, toxicology, PK/PD profiling
- Manufacturing and CMC development
- Initial discussions with FDA
2
Pre-IND Meeting
- Prepare pre-IND briefing package
- Request meeting with FDA (with 60-day review window)
- Get FDA feedback on study design, data, and regulatory path
3
IND Submission Prep
- Compile data and clinical protocols
- Write and assemble IND modules
- Perform internal quality checks and regulatory review
4
Submit to FDA
- Submit electronically (eCTD format)
- FDA assigns IND number
- 30-day FDA review clock starts
5
30-Day Review
- FDA reviews IND for safety and completeness
- Sponsor can begin clinical trials if no clinical hold is issued
- FDA may issue comments, questions, or clinical hold if concerns arise
6
Clinical Trials
- First in-human studies
- Focus on safety, PK, dose escalation
Read more about INDs, see case studies & more on GLOBAL's blog!
Why Choose GLOBAL for IND Support?
GLOBAL has the knowledge to support:
- IND Module 1: Regional
- IND Module 2: Summary
- IND Module 3: Quality
- IND Module 4: Non-clinical Reports
- IND Module 5: Clinical Reports
- Briefing Packages
- Health Authority Interactions
- INTERACT Meetings
- IND Strategy
- Non-clinical
- Clinical
- Regulatory CMC
- Investigator Brochures
- Pathway Designation Support
- Pre-IND Meetings
- Regulatory Operations and Publishing
Frequently Asked Questions About INDs
IND authoring is the process of compiling and writing the content required for a complete FDA IND submission—including summaries, technical reports, and administrative forms.
For planning purposes, we generally tell our clients that a complete IND dossier will take about 2,000 hours across the span of 6 months to prepare. This is greatly dependent on product complexity, data availability, and source document readiness.
Yes. We prepare briefing packages, manage timelines, and provide strategic guidance for pre-IND and INTERACT meetings.
We’ve authored INDs for small molecules, biologics, cell and gene therapies, and advanced modalities across 20+ therapeutic areas.
IND authoring is more than checking boxes—it’s about telling the right story to the FDA. A well-structured, clearly written IND can prevent costly information requests, reduce review times, and secure faster entry into clinical trials
IND authoring demands deep knowledge of FDA and ICH requirements, scientific and clinical data integration, and strategic regulatory communication. Without this expertise, sponsors risk regulator pushback, costly delays, or even a clinical hold that can derail development.
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