Regulatory Affairs Consulting
Clinical Trial
Application Support
28 years of hands-on regulatory affairs experience. Compiling, organizing and coordinating Clinical Trial Application from initial submission and all supporting documents as needed.
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Who We Help
Regulatory support built for teams that can't afford to get it wrong.
Start-Ups
Small-to-Mid-Size Companies
Investigator-Initiated Studies
What We Do
Full lifecycle regulatory support, not just one piece.
From first IND to post-approval, KKW covers the regulatory operations most consultants and CROs handle piecemeal. One experienced point of contact, start to finish.
- Organizing and submitting Initial Clinical Trial (IND) applications
- Filing Initial New Drug Applications in eCTD format
- Compiling Final Clinical Study Reports and Investigator Brochures
- Compiling New Drug Applications and Biological License Applications
- Post-Approval Submission support
- Vendor oversight and regulatory project management
- Application project management
- Regulatory Information Management System (RIMS) support
Regulatory support, packaged around what you need to deliver.
Clinical Trial Application Support
Organizing and submitting Initial Clinical Trial applications; compiling Investigator Brochures, Clinical Protocols, and Briefing Packages.
IND / NDA / BLA Submission Support
Post-Approval & Vendor Management
Regulatory Project Management
Why KKW
One partner.
Every step.
28
Years of experience
5+
Regulatory regions
8
Core service areas
What to Expect
A clear process, from first call to final submission.
01
Discovery Call
Share your project scope, timeline, and regulatory history.
02
Scoped Proposal
Choose the engagement model that fits your team and deliverable.
03
Execution
Hands-on regulatory work, managed end-to-end by Kevin.
04
Delivery & Support
A deliverable you trust enough to submit — and come back to.
Not ready yet?
Get a quick overview of KKW’s services and engagement options.