Drug development consulting
Drug development consulting that drives progress – from potential to approval
Every development journey comes with critical decisions and hidden risks. At KLIFO, we help you anticipate them, align strategy with execution, and build programmes that regulators and investors can trust. That’s how we move potential all the way to approval.
Drug development consulting delivered as a true partnership
At KLIFO, drug development consulting means more than expert advice—it’s about partnering with you to navigate complexity and move your project forward. Whether you’re a biotech start-up seeking funding or a pharmaceutical company entering a pivotal development phase, we help you make the right decisions, at the right time, with the right strategy.
Because developing a drug is never just about the science. It’s about knowing where the risks are. What data regulators expect. And how to build and execute a coherent, fundable, and approvable plan.
Guidance through every phase
Drug development is never linear.
Each phase requires different decisions and expertise. Explore the full journey below.
Regulatory maturity meets operational insight
Most development plans fail not in theory — but in execution. KLIFO combines strategic regulatory knowledge with deep operational experience, ensuring that your program is both visionary and viable.
We support regulatory interactions across global agencies (EMA, FDA, PMDA, etc.) and ensure alignment between your clinical plans and submission requirements. From IND/CTA to NDA/BLA/MAA, we help de-risk your approval path by anticipating what reviewers need—and building it into your program from the start.
Integrated leadership, not just consultancy
At KLIFO, we go beyond advice. Our consultants act as embedded project leads—taking responsibility for timelines, resources, budget, and cross-functional alignment. That means you’re not just getting ideas. You’re getting execution in line with your business objectives.
Whether we step in to cover temporary resourcing gaps or lead end-to-end drug or drug/device development programmes, we become an extension of your team. Fast onboarding, flexible scope, and a bias for action are part of the model.
Typical ways KLIFO supports your project
Some examples of how we can support include:
- Acting as interim Drug Development Project Lead for a large pharma client facing a critical resource gap, driving Phase II preparations and aligning cross-functional teams
- Leading the full development plan for an in-licensed rare disease therapy, from preclinical phase through CTA submission—including CRO selection, regulatory authoring, and investor presentations
Why clients choose KLIFO
KLIFO isn’t a traditional CRO. We’re a North European consultancy powered by senior experts who deliver both strategy and execution. Clients come to us when it really counts—because we don’t just know what to do. We know how to get it done.
Here’s what makes us different:
- Responsiveness: We act quickly—because your timelines matter.
- Consistency: We prioritise continuity—so you work with the same team throughout.
- Collective expertise: You get access to the entire KLIFO brain trust—not just one consultant.
- Embedded collaboration: We integrate deeply into your team—no hand-holding required.
- Tailor-made plans: Every project starts with listening—not templating.
Ready to move forward?
Whether you’re building your first development plan or recalibrating an existing one, KLIFO offers the strategic clarity and operational muscle to help you succeed. Let’s turn potential into progress.
Get in touch to start the conversation—and meet the expert who could be leading your project.