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Advancing Drug Candidates Toward Clinical Development

IND-Enabling

Preparing for an Investigational New Drug (IND) application requires coordinated execution across preclinical development, CMC, regulatory strategy, and program management. BioDuro helps sponsors navigate this critical transition by bringing together the expertise, data generation, and project leadership needed to advance candidates toward first-in-human studies.

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IND Programs Supported
Single Point of Contact
Integrated Program Leadership
Parallel Workstreams
Accelerated Development Execution
Discovery to IND
Connected Scientific Expertise
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Bringing Critical Development Activities Together

Moving a candidate toward IND submission involves more than completing individual studies. Success depends on coordinating scientific activities, managing timelines, mitigating risk, and maintaining alignment across multiple development functions.

BioDuro supports IND-enabling programs through integrated scientific teams, dedicated project management, and development strategies designed to keep programs moving toward regulatory milestones.

Build a clear path forward

Regulatory Strategy & Planning

Project evaluation, regulatory consultation, risk assessment, and development planning designed to support future IND submissions and clinical development goals.

Generate the data needed for IND readiness

Integrated Development Support

Coordinated pharmacology, DMPK, bioanalysis, CMC, and toxicology activities help support informed development decisions and regulatory requirements.

Keep complex programs on track

Program Leadership & Coordination

Dedicated project management teams oversee timelines, budgets, communication, and cross-functional execution throughout development.

Simplifying the Journey to IND

IND-enabling programs often involve multiple vendors, handoffs, and communication challenges. BioDuro helps simplify development through integrated teams that work together across scientific disciplines and development functions.

Single Point of Contact

Streamlined communication and centralized program oversight.

Parallel Development Activities

Coordinated workstreams help reduce delays and support efficient execution.

Integrated Scientific Teams

Connected expertise across discovery, development, and regulatory support functions.

One Quality System

Consistent processes and quality standards throughout program execution.

Supporting the Journey to IND

Program Assessment

Evaluate development objectives, regulatory considerations, timelines, and potential risks to establish a clear development strategy.

Preclinical Development

Execute the studies and supporting activities required to generate decision-ready data and advance development programs.

Cross-Functional Coordination

Align scientific teams, project milestones, documentation, and outsourced activities through centralized project management.

IND Preparation

Support document generation, regulatory interactions, and submission planning activities.

Submission Readiness

Prepare programs for regulatory review and the transition into clinical development.

Related Resources

Learn how integrated development planning, coordinated scientific execution, and regulatory support help accelerate the path to IND submission.

See all resources
11 Months to IND
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11 Months to IND

View our recent IND Enabling Services case study of an 11 months timeline to IND ready....
DPC Case Study
Case study Chemistry Drug Substance

Bridging Discovery and Process Development: A streamlined 18-month path from hit to IND for a CNS project

See how BioDuro advanced a CNS program from hit to IND in just 18 months through integrated discovery and process development....

Start your IND Strategy today!

BioDuro helps sponsors generate the data, documentation, and development plans needed to move candidates from discovery into first-in-human studies with greater confidence.

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