Investigational New Drug (IND) Application
Trusted Support for Investigational New Drug Applications
Investigational New Drug (IND) Application
Accelerating Your Entry Into Clinical Trials with a Compliant, Strategic IND
Submitting a successful Investigational New Drug (IND) application is a critical milestone in the development of any new pharmaceutical, biologic, or advanced therapy. At Bionetwork Consulting, we help drug developers navigate the IND process with clarity, precision, and regulatory confidence—enabling you to transition from preclinical research into human clinical trials without delays or setbacks.
Whether you’re filing your first IND or preparing a complex amendment, our experienced consultants ensure your submission is complete, scientifically sound, and aligned with FDA expectations under 21 CFR Part 312.
Efficient IND Submission Process for Successful Drug Approval
Our Services Include:
Regulatory Pathway Assessment
Determining IND applicability, selecting appropriate regulatory and clinical development pathways, and identifying potential opportunities for expedited programs (e.g., Fast Track, Breakthrough Therapy, RMAT).
IND Strategy & Planning
Developing an IND roadmap tailored to your molecule, indication, and clinical objectives—including timeline planning and data readiness assessments.
Pre-IND Meeting Support
Preparing briefing documents, formulating questions, and facilitating productive interactions with the FDA to de-risk your submission and receive early feedback.
Gap Assessments & Remediation
Reviewing preclinical, CMC, and clinical data to identify deficiencies, ensure data integrity, and close gaps before submission.
