Life cycle management
Sustaining product success beyond approval
Bringing a pharmaceutical product to market is only the beginning. Sustaining its success and expanding its potential requires a strategic, compliant and timely approach to life cycle management (LCM).
At KLIFO, we partner with companies to maintain regulatory approvals, optimise product value and support global expansion through every post-approval activity.
Life cycle management in practice
At KLIFO, we’re highly experienced professionals who integrate strategy with hands-on execution. From planning global variations to managing renewals and extensions, we help ensure that your product stays on the market and remains compliant, without placing extra strain on internal resources.
Our role is not just to keep products alive, but to extend their value: supporting line extensions, adapting to evolving regulatory demands and enabling new market entries. In short, we make sure good medicines don’t just reach patients, but continue to serve them long beyond approval.
Why life cycle management matters
Effective life cycle management is what keeps good medicines on the market and patients continuously protected.
But in practice, it’s a complex process that requires:
- Strategic thinking to maximize potential
- Regulatory insight to plan dossiers and submissions across jurisdictions
- Deep knowledge of post-approval change classifications and regulatory variation procedures
- Timely interaction with health authorities and understanding of evolving expectations
- Cross-functional coordination between CMC, labelling, supply chain, and commercial teams
- Failure to manage the post-approval phase effectively can lead to:
Why effective life cycle management is critical
Failure to manage the post-approval phase effectively can lead to:
- Internal resource overload
- Delays in implementing critical changes
- Compliance breaches and authority queries
- Market withdrawals or missed market-entry opportunities
Guidance through every phase
Life cycle management is never isolated — it’s part of the full drug development journey.
Explore the map to see how post-approval activities connect back to earlier phases, and how each decision shapes long-term success.
From compliance to opportunity: Our strategic focus
Life cycle management isn’t just about maintenance. It’s also a space for growth. At KLIFO, we help our clients explore and plan:
- Geographic expansion strategies (new market applications)
- New formulation and indication submissions (line extensions)
- Strategy alignment and timing of changes
- Life cycle extension tactics for both small molecules and biologics
Our experts understand how regulatory actions impact broader commercial goals — and vice versa. We work with you to create a “red line” of strategic consistency throughout every submission and engagement.
Why choose KLIFO?
At KLIFO, we believe good medicines deserve to reach — and stay on — the market. That requires more than checklists. It requires:
- Highly dedicated consultants: from senior experts to less experienced specialists, aligned with your project requirements.
- Embedded collaboration: we integrate with your team, not just consult from a distance
- Agile delivery: we adjust scope and resources to fit your needs, not the other way around
- Regulatory maturity: we understand the nuance of each agency and how to pre-empt questions
We don’t just help you stay compliant — we help you stay ahead.
Ready to strengthen your product’s future?
Whether you’re managing a portfolio of approved products or preparing for the next wave of submissions, KLIFO can step in where it counts.
Let’s talk about how we can support your life cycle management strategy — and keep your product on track for long-term success.
Get in touch with a KLIFO regulatory expert.