Investigational New Drug (IND) Application
Investigational New Drug Application (IND) Services
Investigational New Drug (IND) Application
Accelerating Your Entry into Clinical Trials
At BioNetwork Consulting, we help pharmaceutical, biotech, and biologics organizations navigate the critical process of Investigational New Drug Application submission with clarity, precision, and compliance. Moving from laboratory research to human trials is one of the most pivotal transitions in drug development — and it demands expert planning, documentation, and regulatory strategy.
Our IND specialists guide you through every stage of this process, ensuring that your submission meets FDA standards under 21 CFR Part 312 and supports a smooth transition into clinical development. Whether you are a startup preparing your first submission or an established sponsor filing multiple INDs, we provide end-to-end support designed to help you succeed — faster and smarter.
What Is an Investigational New Drug Application?
An Investigational New Drug (IND) Application is a formal request submitted to the U.S. Food and Drug Administration (FDA) to obtain authorization to begin clinical trials in humans. It marks the transformation of a potential therapy from preclinical research to clinical testing, bridging scientific innovation and patient impact.
The IND application ensures that:
The investigational product is reasonably safe for human testing.
The proposed clinical protocol is well-designed and scientifically sound.
Qualified investigators will conduct the study following Good Clinical Practice (GCP) standards.
At BioNetwork Consulting, we understand that the IND submission is not just a regulatory requirement — it’s a milestone in innovation. Our goal is to make this process efficient, compliant, and strategically aligned with your clinical objectives.
Our Comprehensive IND Support Services
We provide an integrated suite of regulatory consulting services tailored to your IND submission needs. From early-stage strategy to post-submission follow-up, our approach ensures accuracy, completeness, and alignment with FDA expectations.
Our Services Include:
1. Regulatory Pathway Assessment
Before filing an Investigational New Drug Application, understanding the correct regulatory pathway is essential. Our consultants assess whether an IND is required, evaluate your product type (drug, biologic, or combination), and identify opportunities for accelerated programs such as Fast Track, Breakthrough Therapy, or Orphan Drug Designation.
This early strategic planning helps you minimize risks and optimize your development timeline.
2. IND Strategy and Planning
Each IND is unique — shaped by your product’s mechanism of action, indication, and target patient population. We create a tailored IND roadmap that outlines all required preclinical data, manufacturing (CMC) documentation, and clinical trial protocols.
Our team supports:
Study design and protocol development
Risk assessment and mitigation strategies
IND timeline and submission planning
Regulatory compliance reviews
By combining scientific insight with regulatory foresight, we help ensure that your IND submission is not only compliant but also strategically positioned for success.
3. Pre-IND Meeting Support
Engaging the FDA early can make all the difference in achieving a successful outcome. We help you prepare for Pre-IND (Q-Sub or Type B) meetings to gather regulatory feedback before formal submission.
Our support includes:
Preparing comprehensive briefing packages
Formulating key regulatory questions
Facilitating FDA interactions and follow-ups
Documenting and integrating agency feedback into your IND
These consultations reduce uncertainties, address data gaps, and increase confidence in your submission strategy.
4. IND Submission Preparation
Our regulatory and technical writers assemble and review all components of your IND dossier. We ensure that every section — from investigational plans and investigator brochures to preclinical pharmacology and toxicology data — meets FDA content and formatting requirements.
Our IND assembly includes:
Administrative and technical sections
CMC and manufacturing data
Nonclinical study summaries
Clinical trial protocols
Investigator credentials and IRB documentation
Every submission undergoes internal quality review to guarantee accuracy, completeness, and regulatory compliance.
5. Gap Assessment and Data Remediation
Before filing, we conduct a comprehensive gap analysis to identify missing data, inconsistencies, or noncompliant elements in your preclinical or manufacturing documentation. Our team then works with your internal scientists and QA personnel to remediate issues, ensuring your IND package is complete and audit-ready.
This proactive approach minimizes FDA hold risks and accelerates time-to-clinic.
The BioNetwork Advantage
We don’t just prepare IND applications — we help you build a regulatory foundation for long-term success.
Regulatory Expertise You Can Trust
Our consultants bring decades of experience working within pharmaceutical, biotechnology, and regulatory agencies. We know what the FDA expects and how to present your data for the best possible review outcome.
Tailored, Scalable Support
From early-stage discovery to late-phase development, our IND consulting services scale with your needs. Whether you need guidance on your first submission or strategic support for a global pipeline, we tailor our solutions to fit your resources, goals, and timelines.
Cross-Functional Collaboration
Our multidisciplinary team includes regulatory strategists, CMC experts, clinical scientists, and quality assurance specialists — all collaborating to ensure your IND submission is scientifically rigorous and fully compliant.
Global Regulatory Insight
While the IND process is U.S.-focused, many of our clients operate globally. Our experts help align your IND with international regulatory frameworks such as EMA Clinical Trial Applications (CTA) and MHRA approvals, providing a unified global strategy.
Why the IND Stage Matters
The Investigational New Drug Application phase sets the tone for the entire clinical development lifecycle. A well-structured IND can:
Prevent costly delays or FDA clinical holds
Strengthen scientific and regulatory credibility
Accelerate clinical trial initiation
Lay the groundwork for future NDA or BLA submissions
At BioNetwork Consulting, we understand that every day counts. Our mission is to streamline your IND process so you can focus on what matters most — developing safe, effective therapies that improve patient lives.
Partner with BioNetwork Consulting for IND Success
Whether you are advancing a novel molecule, biologic, or gene therapy, BioNetwork Consulting provides the expertise and support needed to transform your research into a successful clinical program.
From strategy and submission to FDA communications and compliance audits, our IND consultants serve as an extension of your internal team. We ensure every submission reflects scientific integrity, regulatory precision, and strategic foresight.
Let us help you take the next step toward clinical success — confidently and compliantly.
Build the Future of Medicine with Confidence
The path from discovery to therapy begins with a strong Investigational New Drug Application. At BioNetwork Consulting, we bridge innovation and compliance — helping you accelerate your journey to market while maintaining the highest regulatory standards.
Contact us today to learn how our IND experts can help streamline your submission and position your program for long-term success.