Portfolio Management

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.

 

Strategic Portfolio Management

 

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. This leads to a project portfolio management consultant to examine the regulatory compliance across the project portfolio. 

 

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. It’s critical considering so much of a company’s success rides on the decisions of which products to support and which to abandon. Lean portfolio management involves choosing the right portfolio consulting service. Reducing your portfolio risk 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
    • Regulatory Compliance
    • Due Diligence
    • Asset Evaluation Process
    • Current Situation Assessment
    • Strategic Alternatives
    • Technical and Cost Analysis
    • Commercial Analysis
  • International Portfolio Risk
    • Project Programming 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’s Pharmaceutical Consulting Services 

 

Regulatory Compliance Associates® (RCA) has helped thousands of pharmaceutical companies meet regulatory, compliance, quality assurance, and remediation challenges. With more than 20 years of experience with FDA, Health Canada, EU and global regulatory agencies worldwide, Regulatory Compliance Associates® offers leading pharmaceutical consultants. We’re one of the few pharma consulting companies that can help you navigate the challenges associated with industry regulations.

 

Our pharmaceutical consulting firm includes over 500 seasoned FDA, Health Canada & EU compliance consultants and regulatory affairs experts who understand industry complexities. It’s a pharma consultancy founded by industry executives of the pharmaceutical industry. Every pharmaceutical industry consultant on the Regulatory Compliance Associates® team knows the unique inner workings of the regulatory process. 

 

Client Solutions

 

Whether you’re in the product planning, development or pharmaceutical lifecycle management stage or need a remediation strategy for a compliance crisis, Regulatory Compliance Associates® will guide you through every pharma consulting step of the regulatory process and create a customized approach depending on your product and your pharma company’s individual needs. Our clients include:

 

  • Companies new to FDA, Health Canada or EU regulations and the pharmaceutical industry
  • Start-up organizations with novel submissions to 510(k) submissions from multi-national corporations
  • Investment firms seeking private equity due diligence for pre-acquisition and post-deal research
  • Law firms seeking pharmaceutical consulting firm expertise in the remediation of warning letters, consent decrees, 483’s or import bans

 

Regulatory Affairs

 

Regulatory affairs is Regulatory Compliance Associates® backbone. We exceed other pharma consulting companies with industry experts experienced in complexities of the pharmaceutical and biopharmaceutical industries. Our pharma consulting expertise spans all facets and levels of Regulatory Affairs, from Regulatory Support for New Products to Life Cycle Management, to other services like Outsourced Regulatory Affairs, Submissions, Training, and more.

 

As your partner, we can negotiate the potential assessment minefield of pharmaceuticals with insight, hindsight, and the clear advantage of our breadth and depth of knowledge and experience. We offer the following pharma consulting regulatory affairs services for pharmaceutical companies.

 

  • New Product Support
  • Product Lifecycle
  • Other Regulatory Services

 

Compliance Assurance

 

The regulations process surrounding pharmaceutical companies can be tricky for even the most experienced industry veteran to understand. Just one misstep could mean significant and lasting consequences for your business. At Regulatory Compliance Associates®, we offer the pharma consulting experience and pharma consultants necessary to guide you through the quality compliance process.

 

  • Assessments
  • Audits
  • Regulatory Agency Response
  • Preparation and Training
  • Inspection Readiness

 

Quality Assurance

 

Regulatory Compliance Associates® Quality consulting includes assessments, strategy, implementations, staff augmentations, and identification of quality metrics to ensure continuous improvement. Our pharma consultants understand the strategic thinking needed to align your business needs and goals.

 

Regulatory Compliance Associates® pharmaceutical industry consultant are quality experts with experience spanning major corporations and start-ups. Our pharmaceutical consulting firm knows firsthand how to achieve, maintain, and improve quality, and we excel in transferring pharma consulting knowledge to your organization.

 

  • 21 CFR Part 11
  • Data Integrity
  • Manufacturing Support
  • Facility Support

 

Remediation 

 

Regulatory Compliance Associates® has significant experience and a proven approach to managing FDA Warning Letters, Consent Decrees, Remediation and other serious regulatory situations. Our pharma consultants know how to partner with executive, legal, and communication teams, and will assist management with a response that will be accepted by the regulatory agency and be realistic to execute. Regulatory Compliance Associates® pharma regulatory consultants will develop a comprehensive proof book of documented evidence demonstrating the corrective action taken to remediate non-compliant issues.

 

In addition, Regulatory Compliance Associates® pharmaceutical industry consultant will prepare a comprehensive pharma consulting strategy to assist in your remediation efforts, drive continuous improvement, and maintain compliance with the regulations.

 

  • Regulatory Action
  • Warning Letter
  • 483 Observation
  • Oversight Services

 

About Regulatory Compliance Associates

 

Regulatory Compliance Associates® (RCA) provides pharmaceutical consulting to the following industries for resolution of life science challenges:

 

 

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 Regulatory Compliance Associates® scoping process today, please enter your information in the blue form below and click the submit button at the bottom of the webpage. 

 

 

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