The Pros of Portfolio Maintenance Outsourcing

Managing and supporting a product’s lifecycle requires operational excellence. Whether you’re starting development, entering clinical trials, navigating Marketing Authorization Application (MAA) / New Drug Application (NDA) submissions, or actively maintaining compliance—there are a lot of moving parts that require constant attention.

For example, regulatory maintenance post-approval is notoriously challenging, as the requirements can differ by region and country. You not only need up-to-date regulatory intelligence, but the strategic and operational expertise to act quickly and accurately.

Given all the details, it’s easy to lose oversight caused by siloed thinking. In fact, a holistic style of outsourcing could serve you better—saving precious time and resources better applied to product development or portfolio commercialization.

A Long-Term Partnership You’ll Love

At PharmaLex, we’re with you for the long haul. We’ve developed macro-level tools that manage the micro-local regulatory requirements of your products with clarity, ease and measurable results.

With strategic Portfolio Outsourcing, no daily monitoring is needed. Performance management is reported solely through Key Performance Indicators (KPIs). Add on PharmaLex’s other services and realize the benefits of a truly strategic, long-term partnership.

Our extensive experience has taught us that efficient Program Management is critical to reducing time to market launch, avoiding costly compliance mistakes, and ultimately freeing up your resources.

By taking over the maintenance of your portfolio, PharmaLex empowers you to focus on the core competencies that define your success.

Our Approach to Program Management

We develop Portfolio Maintenance Outsourcing models that are tailored to meet our clients’ unique requirements. Successful implementation of each model demands robust Program Management.

Going beyond prerequisites such as plans, reporting and meeting schedules—we bank on actionable big-picture Program Management objectives.

  1. Delineate robust governance structures to understand the roles and responsibilities, decision-making and escalation process at every stage of the partnership.
  2. Champion clear communication protocols that keep accurate, effective and timely information flowing.
  3. Employ holistic risk management that identifies the probability and impact of any given risk, and helps mitigate that risk in time.

KPIs from A to Z

We’re so confident that PharmaLex’s Program Management solutions will deliver tangible positive outcomes that we share the results of our work via KPIs on a regular schedule, as determined by you.

Expect clear responsibilities, guidance and quantifiable insights regarding how well we’re ensuring compliance, enhancing innovation, evaluating the process and much more.

We’re Ready to Help

  • Manage entire product portfolios on a long-term, trusted partnership basis
  • Meet broad strategic and financial objectives
  • Align divergent stakeholders across a company
  • Streamline communication internally and externally
  • Optimize the governance operating model
  • Mitigate risk
  • Establish close working teams through flexible staffing and synergistic personalities
  • Benchmark all adaptations to improve efficiency over the course of the program

Success Stories

To date, PharmaLex outsources Program Management solutions to over 50 pharma companies—leading large projects at every stage of the product lifecycle.  We’re proud to say most of these relationships are ongoing and integral to our clients’ success.

PharmaLex assumed all oversight functions and product coordination for a global product portfolio while the client completed a massive internal restructuring

A scalable team of senior-level experts implemented a highly adaptable program to maintain stability and compliance during the transition period.

To support a client’s major asset purchase, PharmaLex established a local and global structure for all Regulatory Affairs, Pharmacovigilance and Quality Management requirements

The comprehensive solution delivered an efficient MAH transition plan that adheres to all requirements and timelines on an on-going basis.

Let’s tailor a Program Management plan that works for you.

PharmaLex. Confidence beyond compliance.