IND Enabling Studies
Accelerate your innovation and drug discovery
Medicilon’s IND Filing Solutions
We offer a full range of services covering the entire IND-Filling Process
IND Enabling Package
Drug Discovery
CMC Development
Preclinical Research
One-stop, end-to-end solution
From pre-IND strategy through eCTD submission and agency Q&A-chemistry, biology, PK/PD, tox, and CMC under one roof for speed and alignment
Efficient timelines
Clear milestones and a submission-ready data package that anticipates FDA’s 30-day safety review clock after receipt of a complete IND.
Global regulatory reach
IND/CTA enablement for the U.S. (FDA), China (NMPA/CDE), Australia (TGA), and the EU (EMA), harmonized to ICH expectations.
Experienced filing team
Specialists in review concepts, regional requirements, risk assessment, and issue management with structured sponsor-agency communications and follow-up
Specialized Capabilities
Scope of IND Filing Services
Regulatory Strategy & Meetings
- Indication assessment, gap analysis, and route-to-IND roadmap
- Pre-IND/IND meeting planning: briefing books, questions, rationales, and meeting rehearsals
- Regional alignment for FDA/NMPA/TGA/EMA, leveraging ICH M3(R2) for nonclinical scope and timing U.S. Food and Drug Administration
Nonclinical & DMPK
- Pharmacology package design; GLP toxicology strategy (single/multi-dose, safety pharm)
- TK/PK, BA method development & validation, tissue distribution, excretion/material balance
- SEND dataset conversion and quality checks for FDA submissions
CMC (Drug Substance & Drug Product)
- Process chemistry and analytical controls; release/stability methods
- Formulation development and comparability protocols
- Quality modules (eCTD M3 & M2 summaries) aligned with Phase 1 needs U.S. Food and Drug Administration
Clinical (Protocol-Ready)
- First-in-human/proof-of-concept protocol outlines and IB authoring
- Investigator and site documentation planning; safety monitoring framework
eCTD Publishing & Submission
- Complete module authoring, document control, granularity mapping, and lifecycle management
- Electronic submission (eCTD) and post-submission deficiency response management to FDA/NMPA/TGA/EMA with ongoing review tracking.
Our Footprint
Global facilities servicing clients worldwide
IND requirement assessments, content & format, 21 CFR Part 312 compliance, and 30-day review cycle familiarization
IND and ANDA enablement with structured communications/consultations and CDE interactions
ICH-aligned nonclinical expectations adopted locally; pathway selection and timelines.
CTA readiness with ICH M3(R2) nonclinical foundations and regional nuances.
Compliance and Accreditations
Operating in accordance with international standards
Development and Research
Drug development from start to scale
Discovery Handoff & Gap Assessment
Strategic Plan & Risk Register
Study Execution & Data Readiness
eCTD Assembly & QC
Submission & 30-Day Review Support
Strategic Plan & Risk Register
With significant investments in expertise and infrastructure, Medicilon’s CMC (Chemistry, Manufacturing, and Controls) division enhances every stage of the drug development process for optimal efficiency and compliance.
Strategic IND Roadmap and Meeting Package (if applicable)
IND Modules (eCTD): Administrative, Quality (CMC), Nonclinical, Clinical
Investigator’s Brochure (IB), Protocol Synopsis, ICF guidance
SEND datasets and define.xml where applicable
Stability protocols, specs, CoAs, and validation summaries
Response templates for agency information requests
Frequently Asked Questions
FAQs: IND Filing
What is an IND and when do I need one?
An IND authorizes shipment/use of an investigational drug in humans and is generally required before U.S. clinical trials begin; exceptions exist (e.g., certain studies with approved drugs)
How long does FDA take to review an initial IND?
Sponsors must wait 30 calendar days after FDA receives the IND before initiating clinical trials, unless placed on clinical hold.
Which nonclinical studies are expected for a first-in-human IND?
Expect pharmacology, general tox, safety pharmacology, TK/PK, and genotox as appropriate-timed and scoped per ICH M3(R2) for your dose/duration.
Do you publish to eCTD and manage lifecycle?
Yes. We author, QC, validate, publish in eCTD, submit to agencies, and manage follow-up and amendments throughout review.
Can you support China, Australia, and EU filings as well as FDA?
Yes- NMPA/CDE, TGA, and EMA filings are supported, harmonized to ICH with region-specific expectations.
What’s included in your CMC package for Phase 1?
Process and analytical controls, specifications, stability, formulation, and phase-appropriate quality modules per FDA Content & Format guidance for Phase 1 INDs.
