Portfolio management has been embraced by the pharmaceutical and biotech industries because of the unique characteristics of drug development, huge investments, long development timelines, extremely high risk, and need for several products in the pipeline. Portfolio management is about selecting which projects should be funded, how they should be funded, and which should be killed.


Start-up pharmaceuticals and biotechs develop their first products with a laser-like focus, making whatever decisions are in the best interests of each product in isolation. As these companies grow, they continue making product decisions in isolation, unaware of the implications for their other products. Portfolio management is the idea that projects must be valued consistently, allowing investments to be aggregated across the portfolio or compared against each other on an “apples-to-apples” basis.


Pharmaceutical Portfolio Consulting

While other industries may also have several products in their pipelines, no other business sector comes close to approaching the financial risks and failure rates typically associated with a pharmaceutical company’s portfolio.


At even one single pharma organization, the costs for R&D of multiple products can run into the hundreds of millions of dollars — with many of those products destined to fail. That’s why, considering the nature and importance of portfolio management, a company’s decision to seek out pharma portfolio management consultants is an understandable one.


But, once again, with so much of a company’s success riding on the decisions regarding which products to support and which to abandon, choosing the right portfolio management service is as crucial a choice as selecting which specific product development program to continue to fund.


Regulatory Compliance Associates® Inc. Finds the Winners in Your Portfolio

With a wealth of global experience and industry-leading pharmaceutical expertise, Regulatory Compliance Associates® Inc. offers the right mix of former FDA insiders and corporate visionaries to recognize and correctly evaluate the potential of your company’s portfolio of products.


Regulatory Compliance Associates® Inc.’s Portfolio Management services for the Pharmaceutical industry include:


  • Needs Analysis, i.e., Therapeutic Areas and Product Strategies
    • Portfolio Diversification Across Therapeutic Areas
    • Portfolio Diversification Across Technologies
  • Asset Evaluation Process
    • Current Situation Assessment
    • Strategic Alternatives
    • Technical and Cost Analysis
    • Commercial Analysis
  • Risk Reduction via Strategic Alliance and Partnerships
    • Use of Discovery Alliances
    • Use of Development Alliances and Partnering Arrangements
  • R&D Portfolio Prioritization
    • Near-Term, i.e., <5 Years and Long-Term, i.e., <5 Years, Launch Targets
    • Development Strategy
      • Internal vs. Outsourced Development
      • Acquisition vs. In-Licensing
  • Stage-Gate Governance
    • Aligning Product Development with Available Resources
    • Monitor Progress Against Deliverables
    • ROI Accountability


Additional Case Studies


Portfolio Risk Management for the Life Sciences Industry

Strategic Lifecycle Approach to Medical Device Regulation

GMPs for Early Stage Development Projects

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