Contact our FDA consulting company.
Get $1,500 Off Your First Submission Readiness Review as a New Client
Receive Credit When You Refer a Client
FDA Regulatory Compliance and Submission Expert
Regulatory Strategy. Regulatory Operations. eCTD Execution.
FDA Connection Group Inc. (FCG) is an FDA regulatory compliance and submission expert. We help clinical-stage companies prepare, organize, publish, and manage FDA submissions from Investigational New Drug (IND) development through pivotal trials and BLA readiness.
Is Your FDA Submission Really Ready?
Before publishing begins, FCG can review your planned submission for regulatory completeness, eCTD structure, document readiness, lifecycle considerations, and potential validation risks.
The FCG Submission Readiness Review identifies what is ready, what is missing, what could delay the submission, and the actions needed to move successfully toward FDA filing.
Fixed-fee readiness reviews available. Typical turnaround: 2 to 5 business days.
Find Out More About Our Multi-Submission Package for Clients with Multiple Submissions/Events and Milestone-Based Document Requirements
Three Ways FCG Can Help
eCTD Submission Readiness Review
Assess planned submissions before publishing. Identify missing components, placement issues, lifecycle risks, and potential validation problems.
eCTD Publishing and FDA Submission
Organize, publish, validate, and support FDA transmission of eCTD submissions with hands-on regulatory operations oversight.
IND Lifecycle and Regulatory Operations Support
Maintain submission calendars, FDA commitments, document readiness, milestones, and ongoing IND lifecycle activities.
Support Across Key FDA Milestones
FCG supports sponsors across the development lifecycle, including:
- IND submissions and amendments
- Annual reports
- Type C and Type D meetings
- Clinical study reports
- CMC amendments
- Pivotal development readiness
- BLA readiness and submission planning
Regulatory Strategy + Execution
The value of FCG is not limited to publishing. We help sponsors determine what needs to be submitted, how it should be structured, what information is missing, how FDA feedback affects the program, and what needs to happen next.
From strategy through successful transmission, FCG combines senior-level regulatory judgment with direct submission execution.
Ask About Our New Client First Admission Offer During Your Initial Engagement
Learn More About Our Lifecycle Retainer Incentives
Why FDA Connection Group Inc.
FCG combines regulatory strategy, submission operations, quality experience, and hands-on eCTD execution in one practical team.
- Senior-level regulatory and operational experience
- Hands-on eCTD publishing and lifecycle management
- Practical, real-world recommendations
- Direct support for clinical-stage sponsors
- Responsive communication and clear next actions
FCG-OS™ — Regulatory Program Intelligence
FCG is developing FCG-OS™, a regulatory program intelligence environment designed to connect regulatory strategy, program data, submission history, FDA interactions, milestones, document readiness, compliance, risk management, and supervised AI.
FCG-OS™ is intended to give sponsors a clearer operating view of the regulatory program—from IND development through pivotal trials and BLA readiness.
Who We Support
Emerging biotechnology companies
Clinical-stage pharmaceutical companies
Medical device and biologic programs
Virtual biotech organizations
CROs and consulting firms requiring regulatory/eCTD overflow support
Let's Discuss Your Next FDA Submission.
Whether you are preparing an IND amendment, annual report, clinical study report, FDA meeting package, pivotal program, or BLA-readiness activity, FCG can help you determine the most practical path forward.