Portfolio Management Services

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. The science is about selecting which projects should be funded, how they should be funded, and which should be killed.

 

Portfolio Lifecycle Management

Start-up pharma companies 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. Value planning is a concept 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.

 

Project Portfolio Management

While other industries have products in their pipeline, no other business sector comes close to approaching the financial risks and failure rates typically associated with a pharmaceutical company’s portfolio. At one single pharma organization, the CDMO costs for R&D of multiple products can run into the hundreds of millions of dollars — with some in the project portfolio going to fail.

 

Private Equity Portfolio Management

That’s why, considering the nature and importance of project management, a company’s decision to engage pharmaceutical consultants for additional investigation is understandable. From medical instruments to hi tech pharmaceuticals, collectively investigating in the wrong product families for commercialization can be disastrous. 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 consulting service is as crucial as selecting which specific development program to continue to fund.

 

Product Portfolio Management

With a wealth of global portfolio management and industry-leading pharmaceutical expertise, Regulatory Compliance Associates® offers the right mix of former FDA insiders and corporate visionaries to recognize and correctly evaluate the product portfolio of your bio pharma or pharma company.

 

Portfolio Advisory Services

Regulatory Compliance Associates^® portfolio advisory services for the healthcare industry include:

 

• Portfolio Risk Management
  • Asset Evaluation Process
  • Current Situation Assessment
  • Strategic Alternatives
  • Technical and Cost Analysis
  • Commercial Analysis
• International Portfolio Risk
  • Project Programme Portfolio
    • Risk Reduction Controls
      • Strategic Alliance and Partnerships
    • Risk Discovery Alliances
      • Development Alliances and Partnering Arrangements
• Strategic Portfolio Management
  • R&D Portfolio Prioritization
    • Launch Targets
      • Near-Term
      • Mid-Term 
      • Long-Term
  • Development Strategy
    • Internal vs. Outsourced Development
    • Acquisition vs. In-Licensing
• Lean Portfolio Management
  • Outcomes alignment
    • Business outcomes
  • Value stream planning
    • Value steam capacity
• Service Portfolio Management
  • Needs Analysis
    • Therapeutic Areas
    • Product Strategies
  • Portfolio Diversification Across Therapeutic Areas
  • Portfolio Diversification Across Technologies
• Agile Portfolio Management
  • Stage-Gate Governance
    • Product Development
      • Project Portfolio Dashboard
    • Portfolio Monitoring
      • Available Resources
      • Progress Against Deliverables
    • ROI Accountability

 

About RCA

Regulatory Compliance Associates^® (RCA) provides healthcare consulting services to the following industries for resolution of compliance and regulatory challenges:

 

• Pharmaceutical
• Biologic & Biotechnology
• Sterile compounding
• Medical device
• Lab Testing

 

We understand the complexities of running a life science business and possess areas of expertise that include every facet of R&D, operations, regulatory affairs, quality, and manufacturing. We are used to working on the front lines and thriving in the scrutiny of FDA, Health Canada, MHRA and globally-regulated companies.

 

As your partners, we can negotiate the potential minefield of regulatory compliance and regulatory due diligence with insight, hindsight, and the clear advantage of our unique expertise and experience.

 

• Founded in 2000
• Headquartered in Wisconsin (USA)
• Expertise backed by over 500 industry subject matter experts
• Acquired by Sotera Health in 2021

 

About Sotera Health

The name Sotera Health was inspired by Soteria, the Greek goddess of safety, and reflects the Company’s unwavering commitment to its mission, Safeguarding Global Health^®.

 

Sotera Health Company, along with its three best-in-class businesses – Sterigenics^®, Nordion^® and Nelson Labs^®, is a leading global provider of mission-critical end-to-end sterilization solutions and lab testing and advisory services for the healthcare industry. With a combined tenure across our businesses of nearly 200 years and our industry-recognized scientific and technological expertise, we help to ensure the safety of over 190 million patients and healthcare practitioners around the world every year.

 

We are a trusted partner to more than 5,800 customers in over 50 countries, including 40 of the top 50 medical device companies and 8 of the top 10 pharmaceutical companies.

 

 

To begin the RCA^® scoping process today, please enter your information in the blue form below and click the submit button at the bottom of the webpage.