Position Yourself Toward Post-Approval Success with Strategic Compliance Partnerships

So, your drug has reached the post-approval phase of its lifecycle, and you may be wondering, what comes next? Though the road to drug approval is long and rife with challenges, the post-approval phase comes with its own unique demands, including possible market expansion, evolving dosages and indications, and chemistry, manufacturing, and control (CMC) updates. Your team will need experts that can handle a wide variety of renewals and administrative tasks, especially if you are operating across multiple global jurisdictions. To start your journey successfully, familiarize yourself with what post-approval management demands. From there, assess what approach works best for your goals.

What Does Lifecycle Management Entail?

Proactive and effective lifecycle management will require either in-house or external experts that can handle the following tasks: renewals, CMC variations, labeling updates, regulatory information data management, and marketing authorization transfers and withdrawals. To work effectively with regulatory bodies, you will need to establish a thoughtful approach that entails the following:

• Making a streamlined plan that leverages critical viewpoints across your organization.
• Disseminating information effectively to keep stakeholders informed.
• Implementing a plan with defined roles and responsibilities, key performance indicators, and regular status reports.

Since the prospect of effective lifecycle management and regulatory strategy across multiple global jurisdictions can be daunting, many companies opt to work with a regulatory services provider as well as local qualified persons for pharmacovigilance (LQPPVs), who are now required in more than 40 countries.

When is it Time to Work with a Safety and Regulatory Services Provider?

A QPPV and LCM services provider can provide guidance in a variety of areas, including insight into market application expansion as well as end-to-end support for lifecycle management. Their team can also provide access to LQPPVs across multiple jurisdictions, and with access to a network of knowledgeable LQPPVs, your team can benefit from a variety of holistic solutions, including:

• PV professionals with specialized regulatory experience and knowledge
• Streamlined processes and optimized workflows
• Flexible and scalable work groups that can recalibrate to accommodate project demands, market expansions, and regulatory changes
• Adaptive risk management and mitigation strategies

These benefits are only the beginning of what is possible when you partner with a qualified regulatory services provider and gain access to LQPPVs.

Ready to Learn More?

In a recent webinar, IQVIA experts, Vera Dinis, Regulatory Affairs Director, and Ana Pedro Jesuíno, Marketed Product Safety Associate Director, discussed their recommendations for navigating post-approval management, building an effective regulatory approach, and tackling post-approval regulatory obstacles, including divergent health authority expectations and supply chain disruptions. If you are looking for an effective map to traverse your drug’s post-approval lifecycle, download the full white paper, Effective Strategies for Post-approval Lifecycle Management and Local Pharmacovigilance.