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Regulatory affairs: bridging science, strategy and approval
Strong approvals are built decision by decision: what to generate, when to engage, how to document. KLIFO partners with you to anticipate risks, prepare clean dossiers and keep momentum. That’s how we bridge science, strategy and approval.
Regulatory affairs that turn complexity into clarity
At KLIFO, we believe that good medicines deserve to reach the market—but success requires more than promising data. It requires expertise, strategic foresight and flawless execution in navigating the increasingly complex global regulatory landscape.
That’s exactly where our experienced regulatory affairs specialists step in. We partner with biotech and pharma companies—especially where resources, internal expertise or time are constrained—to ensure regulatory strategies are sound, submissions are complete and documentation is robust.
Whether you are preparing for first-in-human studies or maintaining a marketed product, we help bridge the gap between potential and approval.
What is regulatory affairs?
Regulatory affairs is the profession responsible for aligning drug and device development with the requirements of national and international authorities. It ensures that innovations meet all regulatory standards for safety, efficacy and quality before they can reach patients.
At KLIFO, we don’t just interpret the rules—we help you navigate them strategically, anticipate challenges, and leverage regulatory opportunities to accelerate your development path.
In today’s highly regulated environment, regulatory affairs must not only meet national requirements but also navigate global frameworks such as ICH guidelines—anticipating emerging trends to secure approvals across multiple regions.
Regulatory affairs at KLIFO
When you work with KLIFO, you gain more than regulatory expertise—you gain a trusted partner who anticipates regulatory risks, maximises opportunities for accelerated pathways, and helps you avoid costly delays and setbacks.
We integrate seamlessly into your organisation to provide the clarity, confidence and capacity you need to move forward—whether you are preparing your first Clinical Trial Supply or managing a complex international submission.
Regulatory strategy
- GAP analyses
- Regulatory strategy and plan development
- Scientific advice (national authorities, EMA, FDA)
- Strategic regulatory evaluations and recommendations—for example, supporting life science incubators
Regulatory submissions during development
- SME application support
- Advanced Therapeutic Medicinal Product (ATMP) classification
- Expedited development designations, incl. Priority Medicine (PRIME), Rare Pediatric Disease Designation (RPDD) and Break-Through Designation (BTD)
- Expedited approval pathways, incl. fast track applications, priority review and accelerated assessment
- Clinical Trial Applications (CTA)
- Authority meetings (preIND, pre-submission etc.)
- Investigational New Drug Applications (IND)
- Orphan Drug Designation (ODD)
- Paediatric Investigation Plans (PIP)/Pediatric Study Plan (PSP)
- Marketing Authorisation Applications (MAA)
- New Drug Applications (NDA)
- Biologics License Applications (BLA)
Life-cycle management
- RA Product Lead/Project manager
- Strategic regulatory advice for post-approval activities
- Variations
- Line extensions
- Renewals
Submission-ready documentation
- Regulatory writing
- Document review
- eCTD-ready documentation (including bookmarks, hyperlinks, pdf rendering)
- Compiling, publishing and submitting eCTD sequences via trusted partners
- eCTD template support
- Formatting regulatory documentation to meet submission standards
Flexible FTE solutions
- RA Lead/project manager
- RA CMC Officer/Specialist/Senior Specialist
- RA Clinical and non-clinical Officer/Specialist/Senior Specialist
- Interim Head of RA
Guidance through every phase
Regulatory affairs is one part of your broader development journey.
Explore how KLIFO supports you across every phase.
Ready to strengthen your regulatory journey?
Our work spans every development phase — from early strategy to post-approval life-cycle management — and covers all key deliverables: regulatory strategy, authority interactions, submission plans and documentation packages.
We help you answer the critical question: Are you ready to move forward?
Let’s discuss how we can tailor regulatory support to your needs.