Investigational New Drug (IND) Application
What to know about INDs
Embarking on the journey toward your first clinical trial is an important milestone for any biotech company. In the U.S., before going into the clinic, a sponsor is required under 21 CFR 312 Subpart B to submit an Investigational New Drug Application (IND) to the U.S. Food and Drug Administration (FDA). Determining the optimal timing for IND submission can be complex and requires strategic planning.
Why IND authoring requires specialized expertise
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
Who needs an IND?
Researchers studying an unapproved drug or studying an approved drug for a new indication or in a new patient population.
How GLOBAL can help
At GLOBAL, our CMC team are experts on IND Authoring and can work with you to ensure a successful submission. We combine deep scientific knowledge with regulatory expertise to craft IND submissions that are accurate, compliant, and FDA-ready.
53 + INDs Filed Successfully
32 + Satisfied Clients
21+ Writers and Consultants
What can GLOBAL 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
- IND Strategy
- Non-Clinical
- Clinical
- Regulatory CMC
- INTERACT Meetings
- Investigator Brochures
- Pathway Designation Support
- Pre-IND Meetings
- Regulatory Operations and Publishing
Read more at our blog!
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.
Timeline
We can work with your team to turnaround your IND in as little as 30 days from delivery of data. Reach out today to discuss how we can best serve you!
Frequently Asked Questions
What is IND authoring?
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.
How long does IND preparation take?
GLOBAL can prepare and submit a full IND in as little as 30–45 days, depending on project scope and data readiness.
Can you support pre-IND meetings?
Yes. We prepare briefing packages, manage timelines, and provide strategic guidance for pre-IND and INTERACT meetings.
What types of INDs do you support?
We’ve authored INDs for small molecules, biologics, cell and gene therapies, and advanced modalities across 20+ therapeutic areas.
Explore our latest case study showcasing how GLOBAL supported an innovative, clinical-stage biopharmaceutical company in preparing a first-time IND submission that was delivered on schedule and met with a Safe to Proceed letter from the FDA with no follow-up questions.
Confidential. Compliant. Committed to Your Success.
GLOBAL provides trusted regulatory writing and IND authoring services to biotech and pharma companies worldwide. Partner with us to reduce complexity, accelerate timelines, and submit with confidence.
Request IND Support Now - Let’s move your product one step closer to the clinic.
