1,500
IND programs supported annually
8,500+
GLP studies conducted annually
+80%
of novel FDA-approved drugs supported over the last four years
+2,000
bioanalytical methods developed annually
Your IND Program–Simplified and Supported
Every missed milestone can delay your IND submission and slow patient access to life-changing therapies. Our end-to-end program management approach ensures nothing falls through the cracks. From study design to IND writing, we drive timelines, coordinate resources, and resolve issues proactively—so your program moves forward without compromise.
Why Program Management Matters for IND Success
Managing an IND program isn’t just about meeting deadlines—it’s about reducing risk, ensuring compliance, and keeping every milestone aligned with regulatory expectations. Without a dedicated approach, timelines slip, communication breaks down, and critical data can fall through the cracks.
Our program management service exists to solve these challenges. By acting as an extension of your team, we provide strategic oversight, proactive issue resolution, and seamless coordination so your IND submission moves forward without compromise.
Scientific Advisory Services
Gain a clear roadmap for your IND program, with expert guidance from study design through final application.
Risk Mitigation and Timeline Control
Gain a clear roadmap for your IND program, with expert guidance from study design through final application.
10 Regulatory Truths for Biotech Founders
Do not leave your breakthrough to a chance; download this complimentary infographic as a concise checklist to help you stay on track and reach your milestones.
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Unique Capabilities of Our IND Program Management Service
Our program management approach goes beyond coordination—it delivers strategic oversight, regulatory expertise, and operational excellence. With dedicated program managers acting as an extension of your team, we ensure IND programs stay on track, compliant, and ready for submission.
End-to-End Program Management
- Comprehensive oversight from study design through IND submission, ensuring every milestone aligns with regulatory timelines.
- Toxicologists, lab science leads, and project managers collaborate to deliver cohesive, efficient program execution.
- Expert preparation of nonclinical sections, CTD formatting, and SEND compliance for a smooth submission process.
IND Program Management Benefits
Timelines
- Manages project's critical path
- Negotiates/Mitigates timeline changes
- Ensures project team communication
Issue Management
- Facilitates issue escalation, communication, and resolution
- Implements risk mitigation plans for programs
Relationships
- Manages client expectations
- Consolidates points of contact
- Serves as a client and CRL advocate
Communication
- Coordinates and leads kick-off and routine meetings
- Prepares program plans and trackers
- Coordinates sponsor-specific requirements
Would You Like to Estimate Your IND-Enabling Timelines?
Your lead candidate selection should flow seamlessly into the development phase. With just a few simple details, our IND-enabling study and timeline planner will generate an estimated timeline for your investigational New Drug or CTA milestones.
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Supporting All Phases of IND Drug and Product Development
Frequently Asked Questions (FAQs) About IND Program Management
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Can I start with just a few study cages of animals?
Yes, you can start with a single row on a rack within a shared animal holding room. This ‘by-the-row' option is accessible with a minimum three-month contract term. Each row holds up to eight mice cages (rat caging is available at some facilities). This offers a low-cost solution for start-up or pilot research projects with the ability to expand to more rows or racks in that shared room or move to a private room as needed.
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What if I need extra research or technical support for my studies?
Experts are available to perform technical procedures such as dosing, bleeding, euthanasia for necropsy, sample labeling, and aid in anesthesia induction and monitoring. Other general husbandry support is available to aid with vivarium functions such as breeding or weaning animals, measuring body weights or tumor growth, animal identification, animal study prep, and adding or removing non-standard diets (upon request).