FAQ
Questions worth asking before you engage.
Straight answers about how KKW works, what’s in scope, and how engagements are structured.
Working with KKW
What makes KKW different from a large CRO or a solo consultant?
Large CROs hand your project to a junior team after the sales call. Solo consultants often lack the bandwidth to handle complex, multi-jurisdiction programs. KKW sits in between — one senior point of contact who manages your project personally, start to finish, without the overhead.
How quickly can you get started on a project?
Typically within one to two weeks of a signed agreement, depending on current workload. Discovery calls can usually be scheduled within a few business days. Reach out and we’ll confirm availability for your timeline.
Do you work with clients outside the United States?
Yes. KKW has hands-on experience with the FDA, EMA, South American agencies, Australia’s TGA, and African regulatory bodies. Remote engagements are standard — jurisdiction is not a barrier.
Will I be working directly with Kevin, or will my project be staffed out?
Directly with Kevin. There is no junior team, no account manager layer, and no hand-off. The person you speak to in the discovery call is the person doing the work.
Services & Scope
What types of submissions do you handle?
INDs, NDAs, BLAs, post-approval supplements (CBE-0, CBE-30), annual reports, labeling updates, and pre-submission briefing packages. If it goes to a regulatory agency, it’s likely in scope.
Can you help with a submission that's already in progress?
Absolutely. Mid-project engagements are common — gap assessments, document review, taking over a stalled IND, or stepping in ahead of an agency deadline. An initial review call is the best way to assess where things stand.
Do you provide regulatory strategy, or only operational execution?
Both. Strategy without execution is just advice; execution without strategy produces submissions that need to be re-done. KKW handles the full arc — from regulatory pathway analysis and pre-submission planning through final compilation and submission.
Can you manage our CRO or CMO vendors on our behalf?
Yes. Vendor oversight is a core service area — ensuring CROs, CMOs, and regulatory service providers are meeting timeline commitments, quality standards, and regulatory expectations. This is especially valuable for sponsors without a dedicated internal regulatory team.
Engagement & Billing
What are your engagement models?
Three options: Project Support (hourly, scoped to a specific deliverable), Embedded Regulatory Partner (retainer or recurring hours, acting as an extension of your team), and Full-Service Regulatory Management (fixed-fee, end-to-end ownership of a defined program). Most clients start with a discovery call to determine what fits best.
Do you require a long-term commitment?
No. Project Support engagements have no minimum commitment. Retainer arrangements are structured around your program timeline and can be adjusted as scope evolves.
How is billing structured for hourly work?
Hourly engagements are billed against a pre-agreed scope estimate, with regular progress updates. You’ll know what you’re getting into before work begins — no surprise invoices.
Can you provide a fixed-fee quote for a full NDA or IND?
Yes, for well-defined programs. Fixed-fee engagements require a scoping conversation and review of available materials. Once scope is clear, a firm quote can be provided.
Still have questions?
The fastest answer is a conversation.
If your question isn’t here, reach out directly. Most engagements start with a 30-minute discovery call — no commitment, just a clear-eyed conversation about your project.