IND Lifecycle Support
IND Lifecycle Support
FDA Connection Group Inc. provides operational IND lifecycle support. We help clinical-stage companies manage IND submissions, amendments, annual reports, document readiness, eCTD publishing, FDA commitments, and program milestones from IND activation through BLA readiness.
Submission Planning
Strategic planning for a confident IND and beyond.
Lifecycle Management
Ongoing support for amendments, reports, and commitments.
Program Readiness
Keep your program on track from IND to BLA.
How We Support
How We Support the IND Lifecycle
We provide end-to-end operational and regulatory support to help clinical-stage companies successfully manage their IND throughout its lifecycle, from initial submission to BLA readiness.
IND Submission Planning and Activation
Develop tailored regulatory strategy, program design, and submission plans to support a successful IND and rapid activation.
Annual Reports and Amendments
Plan and prepare annual reports, protocol amendments, and safety updates to maintain compliance and program momentum.
eCTD Lifecycle and Document Readiness
Create, manage, and publish eCTD submissions with complete, accurate, and inspection-ready documentation.
FDA Commitments, Meetings, and Milestone Tracking
Track FDA commitments, prepare meeting packages, and manage key milestones throughout the IND lifecycle.
Support Across the IND Lifecycle
We provide continuous support at every stage of your IND, helping you navigate regulatory requirements, manage submissions, and stay prepared for what’s next.
Pre-IND
Strategy, meeting prep, and initial feedback.
IND Submission
Preparation, eCTD publishing, and FDA review.
Protocol Amendments
Manage changes and maintain compliance.
Annual Reports
Plan, prepare, and submit on time.
Clinical Study Reports
Support ongoing development and reporting.
FDA Meetings
Prepare briefing packages and follow-up.
CMC Updates
Manage manufacturing, CMC changes, and filings.
Phase 3 Readiness
Strategic planning for late-stage success.
BLA Readiness
Build toward a seamless transition to BLA.
What IND Lifecycle Support Includes
Our comprehensive services help you stay organized, compliant, and ready at every stage of your IND, with practical, hands-on support tailored to your program.
Submission Calendar and Planning
Create a master submission calendar, align timelines, and plan for upcoming filings, reports, and meetings.
Regulatory Gap/Readiness Review
Assess your current program against FDA requirements and identify gaps, risks, and opportunities.
Document Tracking and Readiness
Manage document development, version control, and readiness across the IND lifecycle.
Cross-Functional Program Alignment
Work with your internal teams to align regulatory, clinical, CMC, and commercial activities.
Why Sponsors Choose FCG
We combine deep regulatory expertise, real-world experience, and a collaborative, hands-on approach to help clinical-stage companies keep their IND programs on track.
Hands-On eCTD Experience
Deep expertise in eCTD publishing and FDA submission requirements.
Practical Regulatory Operations
Actionable, real-world guidance based on extensive IND and clinical development experience.
Responsive Partnership
Direct access to experienced professionals who understand your goals and timelines.
Integrated Strategy + Execution
We link regulatory strategy, submission execution, and ongoing program support.
Let's Work Together
Let's Support Your IND Program
Whether you’re planning an IND, preparing for an upcoming submission, an annual report, or need ongoing lifecycle support, our team is here to help. Discuss your goals and how we can keep your program on track.