The QxP Approach Makes the Difference

Why Achieving Sustainability is Crucial for Patients

Sustainability is crucial to ensure a continuous supply of quality medicines to patients. Achieving sustainability can feel elusive – to many biopharma companies – but it doesn’t have to be. In fact, in 12 out of 12 recent partnerships, QxP’s clients have not only achieved compliance but have maintained that compliance since the completion of their engagement with QxP. What is QxP doing that other GMP consultancies are not?

1. Emphasis on long-term sustainability & knowledge transfer

  • QxP's mission is "to ensure our clients meet their business, quality, and compliance goals simultaneously… via … technical expertise, educational tools, mentoring and execution support."
  • QxP focusses not just on "fixing a problem" but on leaving your organization stronger. A recent client shared "What makes QxP unique is their expert talent & ability to augment your organization... They leave your organization stronger."
  • QxP uses a "player/coach" model: QxP experts pair with client staff ("twins") so the client’s team learns by doing, rather than simply outsourcing all the work.
  • QxP has developed our own training/education platform called Virtuosi® (immersive/interactive) to build workforce capability.

Why that matters: Many consulting firms focus purely on delivering a deliverable (an audit, remediation plan, SOPs) and then leave. QxP positions itself as building capability within the client’s company, so that once the engagement ends, the client is better able to maintain quality systems and compliance. If your organization is looking for that kind of "build vs just fix" model, then QxP's approach is a differentiator.

2. Consultant team profile & domain depth

  • The QxP team comprises "executive quality leaders," "compliance experts across all GMP aspects," "technical experts in manufacturing, analysis, and engineering," and "successful change leaders."
  • The QxP team have been in their clients' shoes: "Our consultants bring more than 27 years of global experience at the highest levels of the biopharmaceutical industry."

Why that matters: When you engage a consulting firm, the depth of the team and their real-world experience matters a great deal in regulated environments. QxP brings senior-level talent, not just junior auditors, who know not only how to identify risks but know how to mitigate and ultimately resolve such risks.

3. Broad technical/regulatory scope & specialized training instruments

  • QxP's core competencies and areas of expertise provide comprehensive support across the broad range of manufacturing disciplines: Enterprise Quality & Compliance Risk Assessment, FDA inspection readiness & regulatory action support, quality system assessments & maturity ranking, structured gap assessments, data integrity assessments, etc.
  • In particular, QxP is facile in complex manufacturing environments: advanced manufacturing, aseptic processing, biotech, vaccines, sterility assurance, engineering, microbiology, etc.
  • QxP also offers its educational training tool, Virtuosi®, including virtual reality / immersive training for aseptic/microbiology/CGT (cell & gene therapy) manufacturing.

Why that matters: Many GMP consulting firms may cover more 'traditional' dosage forms or compliance issues but may not have such an explicit training platform or deep domain breadth in advanced therapies/sterile manufacturing. For high-complexity area manufacturers (aseptic/biotech/CGT), this could be a relevant differentiator.

4. Partnership mindset and client alignment

  • QxP's value statement includes "Partnership" as a core value: "Our clients’ success is our success. By educating employees, we build critical thinking and reduce errors. We collaborate with our clients..."
  • QxP focuses on alignment: "In our consulting projects, QxP differentiates itself... by focusing on long-term sustainability and establishing strong partnerships with a client’s management and staff that we are aligned to support."

Why that matters: Consulting firms vary in how embedded they become with the client’s team. A "partnership" orientation means QxP leans toward joint working, mentoring, and enabling rather than the "we do it, you pay" transactional model.

5. Unique training/education offer (Virtuosi®)

  • Virtuosi® is an immersive workforce education and training platform, enabling interactive, hands-on learning in aseptic/microbiology manufacturing environments. It is available in six languages.

Why that matters: Training and capability development is a value-add not always offered by traditional consulting firms. If your organization is concerned with not just remediation but up-skilling staff and building capability, this is a differentiator.

6. Focus on value-based consulting and avoiding "just more consultants"

  • "For decades … many of us in industry spent too much money and time on armies of consultants while receiving too little in the way of sustainable, high-impact results. This realization inspired us to launch a revolution. ... We recognized the critical need in compliance consulting for a value-based option."

Why that matters: QxP does not employ a "body-shop" model. If you’ve experienced engagements where consultants came in, did audits, left you with a long list of things, but your organization didn’t really improve, QxP makes the difference.

Summary— How the QxP Approach Makes the Difference

QxP stands out in multiple ways:

  • Our solutions support knowledge transfer, building client capability, rather than just delivering remediation.
  • We bring senior-level, deep domain expertise including manufacturing, engineering, microbiology, sterile/biotech operations.
  • We provide a training/education platform (Virtuosi®) as part of our solutions.
  • We adopt a partnership model—collaborating with client teams ("player/coach") rather than simply acting as advisors.
  • We provide value-based consulting, not just staffing or auditing.
  • We cover a broad and advanced technical/regulatory scope, suited for high complexity environments (aseptic, CGT, biotech).

When that difference matters to achieving sustainability and continuous supply of therapies to patients

If your organization is dealing with one or more of the following, QxP's unique differentiators may matter more:

  • A facility/manufacturing line needing sustainable capability improvement (not just a one-off audit).
  • A complex product or process (sterile fill/finish, biotech, cell & gene, microbiology heavy).
  • An organizational goal of building internal talent and quality culture, not just "fix it and exit."
  • Wanting a consultant that will partner with you long term and embed with your team.
  • Wanting educational solutions alongside consulting to upskill staff for sustainable compliance and business efficiency.

Sustainability is crucial to ensure a continuous supply of quality medicines to patients. Achieving sustainability can feel elusive – to many biopharma companies – but it doesn’t have to be. In fact, in 12 out of 12 recent partnerships, QxP’s clients have not only achieved compliance but have maintained that compliance since the completion of their engagement with QxP. What is QxP doing that other GMP consultancies are not?

1. Emphasis on long-term sustainability & knowledge transfer

  • QxP's mission is "to ensure our clients meet their business, quality, and compliance goals simultaneously… via … technical expertise, educational tools, mentoring and execution support."
  • QxP focusses not just on "fixing a problem" but on leaving your organization stronger. A recent client shared "What makes QxP unique is their expert talent & ability to augment your organization... They leave your organization stronger."
  • QxP uses a "player/coach" model: QxP experts pair with client staff ("twins") so the client’s team learns by doing, rather than simply outsourcing all the work.
  • QxP has developed our own training/education platform called Virtuosi® (immersive/interactive) to build workforce capability.

Why that matters: Many consulting firms focus purely on delivering a deliverable (an audit, remediation plan, SOPs) and then leave. QxP positions itself as building capability within the client’s company, so that once the engagement ends, the client is better able to maintain quality systems and compliance. If your organization is looking for that kind of "build vs just fix" model, then QxP's approach is a differentiator.

2. Consultant team profile & domain depth

  • The QxP team comprises "executive quality leaders," "compliance experts across all GMP aspects," "technical experts in manufacturing, analysis, and engineering," and "successful change leaders."
  • The QxP team have been in their clients' shoes: "Our consultants bring more than 27 years of global experience at the highest levels of the biopharmaceutical industry."

Why that matters: When you engage a consulting firm, the depth of the team and their real-world experience matters a great deal in regulated environments. QxP brings senior-level talent, not just junior auditors, who know not only how to identify risks but know how to mitigate and ultimately resolve such risks.

3. Broad technical/regulatory scope & specialized training instruments

  • QxP's core competencies and areas of expertise provide comprehensive support across the broad range of manufacturing disciplines: Enterprise Quality & Compliance Risk Assessment, FDA inspection readiness & regulatory action support, quality system assessments & maturity ranking, structured gap assessments, data integrity assessments, etc.
  • In particular, QxP is facile in complex manufacturing environments: advanced manufacturing, aseptic processing, biotech, vaccines, sterility assurance, engineering, microbiology, etc.
  • QxP also offers its educational training tool, Virtuosi®, including virtual reality / immersive training for aseptic/microbiology/CGT (cell & gene therapy) manufacturing.

Why that matters: Many GMP consulting firms may cover more 'traditional' dosage forms or compliance issues but may not have such an explicit training platform or deep domain breadth in advanced therapies/sterile manufacturing. For high-complexity area manufacturers (aseptic/biotech/CGT), this could be a relevant differentiator.

4. Partnership mindset and client alignment

  • QxP's value statement includes "Partnership" as a core value: "Our clients’ success is our success. By educating employees, we build critical thinking and reduce errors. We collaborate with our clients..."
  • QxP focuses on alignment: "In our consulting projects, QxP differentiates itself... by focusing on long-term sustainability and establishing strong partnerships with a client’s management and staff that we are aligned to support."

Why that matters: Consulting firms vary in how embedded they become with the client’s team. A "partnership" orientation means QxP leans toward joint working, mentoring, and enabling rather than the "we do it, you pay" transactional model.

5. Unique training/education offer (Virtuosi®)

  • Virtuosi® is an immersive workforce education and training platform, enabling interactive, hands-on learning in aseptic/microbiology manufacturing environments. It is available in six languages.

Why that matters: Training and capability development is a value-add not always offered by traditional consulting firms. If your organization is concerned with not just remediation but up-skilling staff and building capability, this is a differentiator.

6. Focus on value-based consulting and avoiding "just more consultants"

  • "For decades … many of us in industry spent too much money and time on armies of consultants while receiving too little in the way of sustainable, high-impact results. This realization inspired us to launch a revolution. ... We recognized the critical need in compliance consulting for a value-based option."

Why that matters: QxP does not employ a "body-shop" model. If you’ve experienced engagements where consultants came in, did audits, left you with a long list of things, but your organization didn’t really improve, QxP makes the difference.

Summary— How the QxP Approach Makes the Difference

QxP stands out in multiple ways:

  • Our solutions support knowledge transfer, building client capability, rather than just delivering remediation.
  • We bring senior-level, deep domain expertise including manufacturing, engineering, microbiology, sterile/biotech operations.
  • We provide a training/education platform (Virtuosi®) as part of our solutions.
  • We adopt a partnership model—collaborating with client teams ("player/coach") rather than simply acting as advisors.
  • We provide value-based consulting, not just staffing or auditing.
  • We cover a broad and advanced technical/regulatory scope, suited for high complexity environments (aseptic, CGT, biotech).

When that difference matters to achieving sustainability and continuous supply of therapies to patients

If your organization is dealing with one or more of the following, QxP's unique differentiators may matter more:

  • A facility/manufacturing line needing sustainable capability improvement (not just a one-off audit).
  • A complex product or process (sterile fill/finish, biotech, cell & gene, microbiology heavy).
  • An organizational goal of building internal talent and quality culture, not just "fix it and exit."
  • Wanting a consultant that will partner with you long term and embed with your team.
  • Wanting educational solutions alongside consulting to upskill staff for sustainable compliance and business efficiency.

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