21 CFR Part 312 · Investigational New Drug Applications
IND Preparation & Submission
From pre-IND feedback to an IND in effect. ADB authors, assembles, and submits Investigational New Drug applications under 21 CFR Part 312 — extending the same disciplined regulatory practice we built in medical devices to drug development programs.
Schedule a ConsultationA Growing Practice
A Regulatory Practice That Now Spans Drugs and Devices
For years ADB's core work has been guiding medical devices through FDA. That discipline — verified sources, defensible timelines, no assumption left unstated — now extends to the drug side of the agency. Our IND practice covers small molecules and complex programs alike, including Schedule I controlled substances and psychedelic-derived drug products, where DEA coordination and scheduling strategy run alongside the FDA pathway.
Scope of Work
What the Engagement Covers
IND Authoring & eCTD Compilation
Modules 1 through 5, built to current FDA technical validation standards.
CMC Gap Assessment
A written findings report before anything is filed.
Prior FDA Interaction Review
Advisory review of prior FDA interactions, including written pre-IND meeting feedback.
FDA Forms Preparation
Forms FDA 1571, 1572, and 3674 preparation.
ESG Submission & Review Clock Management
Submission through the FDA Electronic Submissions Gateway and management of the 30-day review clock.
DEA Coordination
For scheduled substances — advisory through full-coordination scope, matched to the program.
Where Every Engagement Starts
Every Engagement Starts With a Readiness Assessment
Before ADB commits to a submission timeline, we run a fixed-scope readiness assessment of your source materials — nonclinical, clinical, and CMC. It ends in a written verdict: GO, GO WITH GAPS, or HOLD. You learn exactly what stands between your program and a fileable IND before the larger engagement begins, and every downstream assumption is recorded in an inputs register — nothing is priced or promised on faith.
Engagement Structure
Two Ways to Structure the Work
Assembly & Submission
Your source content is ready. ADB assembles, authors the regulatory narrative, compiles the eCTD, and submits.
Typical path: 14–16 weeks to submission
Full IND Development
Source content needs development or remediation. ADB builds the gaps — CMC sections, nonclinical summaries, protocol refinement — then assembles and submits.
Typical path: 18–20 weeks to submission
Never Bundled
Optional Services, Never Bundled
U.S. Agent
Required representation for foreign sponsors under 21 CFR 312.23; ADB serves as your named U.S. Agent on Form FDA 1571.
Sponsor Obligations Support
Ongoing support for sponsor responsibilities under 21 CFR 312.50–312.58, including IND safety reporting and annual reports.
Fractional Regulatory Director
Senior regulatory leadership on a monthly retainer, without the full-time hire.
Expedited Programs
Orphan Drug Designation at the IND stage and Breakthrough Therapy readiness, where the data supports it.
Why ADB
Why Sponsors Choose ADB
- Fact-gated planning: unconfirmed variables are surfaced in writing, not buried in assumptions
- Lean, defensible scopes: task-level work plans that stand up to scrutiny from operators who have run CROs themselves
- One accountable U.S. partner: from readiness assessment to an IND in effect
Led by Andre Butler, CQA, CCRP — 28+ years, 15+ FDA 510(k) clearances, 11 years on a Class III PMA program. Meet the team →
Not Sure Which Option Fits?
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