Trusted by the World’s Leading Pharma and Biotech Companies
QxP is recognized globally as a premier consulting firm with extensive experience in the life sciences industries. Our team of deeply skilled experts possess a consistent track record of high impact results, delivering winning outcomes in situations of intense regulatory scrutiny. Our unique approach includes offering a suite of services ranging from operating as executive coaches and interim operational leaders to mentoring department leaders and frontline operators. Establishing enduring, meaningful relationships with learning and development, manufacturing, and quality departments is key to our holistic approach.

PROVEN SUCCESSFUL OUTCOMES
Consulting Service Areas
QxP can serve as your bridge to successful commercialization, bringing our experience and expertise in analytical methods, manufacturing and regulatory filings to ensure submissions meet regulator’s tough standards. Our mentorship/partnership programs ensure your team develops the skills and capability needed to meet ongoing commercial demands.
QxP partners with you to understand your unique set of cultural and organizational challenges, then utilizes our expertise in adult training and education to develop and implement programs that both educate and empower individual employees by efficiently delivering rapid onboarding, workforce upskilling, or specific education and training requirements.
The rapid development times of novel therapeutics mean increased scrutiny and risk for both early clinical work and technical CMC. Additionally, commercial GMP operations loom quickly, challenging our abilities in scale-up and aseptic operations. Our team has real-world experience across the cell and gene life cycle and in commercial aseptic operations. We will work with you to address these challenges and we can help you develop practical solutions to managing these risks, tailored for your product, your team and your facilities.
Regulatory compliance gaps must be addressed systemically, efficiently, and sustainably. As former industry leaders, we use our collective remediation experience to partner with your organization in developing and writing agency responses, creating structured remediation programs and guiding the systemic execution of these plans to ensure rapid sustainable solutions.
QxP provides the expertise you need to quickly identify the key issues and logistical requirements that matter most in a regulatory inspection. We provide hands-on support for your Quality and Operations organizations to ensure inspection readiness. Our experts prepare your team, through coaching and mock audits to effectively interact with regulators and accurately represent the strategy and impact of the issues.
QxP is a leader in quality risk management, and has created targeted risk assessment and risk modeling tools which we can deploy to help you quantify your specific business risks, implement effective risk mitigation plans and provide ongoing insights to maintain and improve your corporate quality standards.
When True Experience Matters
QxP supported a client who received a complete response letter (CRL) defining multiple deficiencies in their initial submission to the FDA for a groundbreaking antibody-drug conjugate for triple negative breast cancer. After initially ensuring the facility, manufacturing, and laboratory teams were prepared to manufacture their first major commercial product, QxP SMEs reviewed and revised the analytical and manufacturing sections for resubmission. Our expertise removed guesswork for the client, accelerated the approval process by six months, and enabled a multi-billion dollar acquisition deal by a flagship pharmaceutical firm.


Virtuosi VR Interactive Experiences
By incorporating comprehensive course content with immersive virtual reality, Virtuosi provides a unique ability to enter, explore, and learn in our state-of-the-art virtual manufacturing and laboratory facilities.
The realistic virtual learning environment enhances learning objectives while helping learners gain confidence. This reduces SME time and eliminates the need for costly specialty training facilities and supplies, all while removing real-world risk to production equipment and facilities.
Learn More About Virtuosi

Crystal Mersh
Crystal Mersh
Crystal Mersh is the founder, president, and CEO of QxP. She holds a bachelor’s degree in chemistry from Fairmont State University and has spent 25 years in the pharma industry in senior level positions with companies such as Novartis, Mylan, Sanofi, and Allergan. Her experience at these companies led her to create a revolutionary approach to consulting, delivering long-term transformational change in the pharma industry with the founding of QxP in 2012. Crystal also has extensive experience in remediation, consent decree management, warning letter resolution, and continuous improvement for quality systems, workflows, and operations. She has led QxP in numerous, global engagements, specializing in regenerative medicine and immunotherapies, and has committed QxP to influencing regulatory and industry standards in the pharma industry while setting the platinum standard in life sciences education. The development and launch of Virtuosi are a key part of Crystal’s vision for leading-edge pharma education.

Uriel Kusiatin
Uriel Kusiatin
Uriel Kusiatin is the chief financial officer for QxP. He holds a bachelor of science degree from the Technical University of Denmark as well as an MBA in strategy and finance from the Wharton School. Uriel has more than 20 years of experience in the life sciences industry as a C-level executive and management consultant to both small startups and large pharma organizations. He has advised senior executive teams, multiple board of directors, and investors on business strategy, commercialization, operational execution, and financial management. Over the past 8 years, Uriel has been CFO and CEO for a venture-backed liquid biopsy company focused on breast cancer detection and other women’s cancers. He led the company through $50 million in capital raises, a sale to a private equity firm, and, most recently, the sale to a publicly traded molecular diagnostics company.

Brian Duncan
Brian Duncan
Brian Duncan is the chief operating officer for QxP, providing operating oversight for all global consulting engagements. Brian graduated from the U.S. Air Force Academy and then completed his bachelor’s degree in chemistry at the University of Texas at San Antonio. Since 2014, he has held various executive leadership positions, including senior vice president of global sales and deployment for Virtuosi. He is a seasoned leader, having held numerous senior and executive positions within the pharma industry. Brian has also worked with dozens of global pharma companies developing, deploying, and managing various strategic programs. These programs focus on remediation, mergers and acquisitions, site expansions, global standards alignment, education, and local capability enhancements. In addition, he has developed and led the daily execution of six successful warning letter and consent decree programs. All programs resulted in full resolution within record time (typically 12 months or less) with results that were sustained for several years at the local, regional, and global levels.

Nicole Monachino
Nicole Monachino
Nicole Monachino is the chief legal officer and Head of business operations for QxP. She graduated from Hiram College with a bachelor’s degree in management and received her juris doctorate at the University of Notre Dame Law School. Nicole is a results-oriented business executive and attorney and a trusted advisor to cross-functional teams that drive strategic corporate initiatives. Combining this diverse experience, Nicole excels in identifying creative solutions to complex problems in all aspects of GxP remediation, pharmaceutical development, manufacturing, sales, and marketing. She navigates the complex legal and business framework of the pharma industry for QxP and is recognized for building strong relationships with senior business leaders, during times of ambiguity and crisis.

Robin Mersh
Robin Mersh
Robin Mersh is the senior vice president of Sales for QxP. He graduated from Queen Mary University of London with a bachelor’s degree in history and politics and is an accomplished senior sales executive with over 20 years of success selling advanced technologies, including virtual reality, broadband, cloud, data centers and e-business. His sales focus is on the flagship product, Virtuosi — virtual reality education for the pharma industry in manufacturing operations and biotech. Robin is an expert in strategic leadership, management, sales, channel and partner management, and cultivating client relationships. He is also able to identify opportunities for facilitating growth within an organization and securing positive results.

Mike Levitt
Mike Levitt
Mike Levitt is the vice president of strategic operations for QxP. He graduated from the University at Buffalo and is a veteran operations senior executive with more than 40 years in the pharma industry working at Eli Lilly, Solvay, and entrepreneurial biotech companies. At QxP, Mike leads project teams, supporting clients with new product approvals, quality systems remediation, and operational improvements. In addition, he specializes in regulatory inspection preparedness education and assists clients in responding to enforcement actions. Mike has devoted his career to bringing innovative health care products to patients around the world.

Becky Brewer
Becky Brewer
Becky Brewer is the strategic practice lead at QxP. A graduate of Mount Hoilyoke College specializing in biology and chemistry, Becky has more than 25 years of direct pharma experience in the areas of quality, compliance, and continuous process improvement. She has held numerous positions within the pharma industry, specializing in cleaning validation and engineering, process validation, production controls, and manufacturing. Additionally, Becky has significant experience with risk assessment, control strategies, continued process verification, and manufacturing facility design. She teaches for ISPE, PDA, and the University of Wisconsin, as well as other conference organizations.

Bob Ferer
Bob Ferer
Robert (Bob) Ferer is the vice president of consulting operations at QxP. A graduate of the State University of New York at Stony Brook, Bob is an engineering chemist and has more than 29 years of direct pharma experience with the design, build, startup, and management of facilities, specializing in aseptic manufacturing. His operational experience covers all aspects of pharma operations, from receipt of raw materials through inspection, final packaging, and shipping of finished products. In addition to operations expertise, Bob has been instrumental in multiple projects related to new facility design and startup. This includes developing and executing project master plans, schedules, and budgets, performing hands-on validation, design review, and equipment startup, and commissioning. He provides high-level consultation to clients on regulatory and compliance issues related to operations, engineering, and facility design for US and EU markets.

Kathy Meyer
Kathy Meyer
Kathy Meyer is the vice president of program management for QxP. She graduated from the University of Colorado Boulder with a degree in molecular, cellular, and development biology and completed her master’s in business with an emphasis in technology management. Kathy joined the pharmaceutical industry in 1993 and has held several executive leadership roles in the fields of quality, compliance, manufacturing, supply chain, program management, and business development. In addition, she has supported and managed regulatory inspections and remediation programs and also successfully implemented multimillion-dollar projects and launch preparation strategies to improve time to delivery for patients. At QxP, Kathy serves as editor and program manager for Virtuosi. She has been recognized as a "Rising Star" by the Healthcare Business Women’s Association.

Vanessa Figueroa
Vanessa Figueroa
Vanessa Figueroa, Pharmaceutical Microbiologist and Consulting Partner, has more than 13 years combined experience in Pharmaceutical, Biotechnology and Medical Device industries. Vanessa has expertise in sterility assurance, environmental and utilities monitoring programs and quality control laboratory management. Her consulting experiences have spanned both domestic and international large pharmaceutical companies, applying both US and global regulatory standards of quality. Her current role as Executive Director of Microbiology for QxP is focused on the development of Virtuosi, an innovative and revolutionary education and training product for the pharmaceutical industry. Vanessa has a Bachelor’s degree in Molecular Biology from State University of New York at New Paltz and a Master’s degree in Molecular Biology and Microbiology from San Jose State University. She is an active and publishing member of several professional organizations, such as the Parenteral Drug Association, American Society of Microbiology and Association for Women in Science.

Mark Roache
Mark Roache
Mark Roache is a consulting team lead for QxP. He graduated from the University of Leicester with a Master of Science degree in biomolecular technology and has been in the pharma industry for more than 10 years addressing quality and regulatory issues. Mark specializes in organizational change management, facility startup, and commercialization and quality systems design.
Our Consulting Team
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 and so QxP was born.
We are an organization fueled by the passion to do what is right and provide the pharma, biotech, and life sciences industries with the consulting talent it deserves. QxP is demonstrating to the industry that consultants can work with integrity and that our approach to partnering with your organization will bring impactful, long-term value.
Our team, composed of industry leaders and educators, administers practical operational experience. Our thought leadership enables the development of implementation processes for effective and consistent aseptic manufacturing, testing, and compliance tailored for your unique products.
WHO WE ARE:
- Utilizes agile development methodology and global regulatory standards to develop our content
- Consists of over 20 members, including 9 VR developers
- Actively participates in industry organizations, such as PDA and ISPE, including engaging in influential advisory boards such as the PDA Advanced Therapy Medicinal Products Advisory Board
- Includes published authors of scientific texts and technical papers, featured in TED, NPR, New York Times

Our Development Team
Our Development Team is a multi-disciplinary group of scientific and technology experts within the microbiology, chemistry, manufacturing, advanced therapies, adult learning, and cutting-edge VR development fields. The scientific experts behind Virtuosi are leaders in the pharmaceutical and biopharmaceutical industries, focused on educating through consulting engagements, professional organizations, participation in advisory boards, and direct to learners via YouTube and TED Talks.
Our technology experts specialize in AR/VR/Video production, bringing their highly skilled engineering, scientific, game design and video production skills to translating leading edge science into simple and engaging educational content.
- Utilizes agile development methodology and global regulatory standards to develop our content
- Consists of over 20 members, including 9 VR developers
- Actively participates in industry organizations, such as PDA and ISPE, including engaging in influential advisory boards such as the PDA Advanced Therapy Medicinal Products Advisory Board
- Includes published authors of scientific texts and technical papers, featured in TED, NPR, New York Times
Learn More About Virtuosi

What makes QXP unique is their expert talent & ability to augment your organization to accomplish your business objectives. They leave your organization stronger. I cannot recommend QXP highly enough.”
Scott Canute, former President Global Manufacturing Eli Lilly and Company and Genzyme Corp., Current Executive Board Director Immunomedics, Inc.
Thank goodness we've had QxP present at (the site) for the past month. We are much better prepared now than we ever would have been on our own. We are not only aware of the issues, but your recommendations for addressing them have been spot on.”
Head of Global Compliance for a Global Company Speaking About a Warning Letter Remediation Support Program
The selection of QxP as the third party expert for our Warning Letter remediation was the best decision we made.”
Senior VP of Operations for a global pharmaceutical company
Our Values
Understanding. A desire to learn. Organizational momentum. Sustainability. Collectively, these attributes make the difference between success and failure for a person or organization. None of these attributes are easily achieved without a purposeful and evolving strategy, fused with constantly aligned execution.
The depth and breadth of practical knowledge demonstrated by our technical and compliance experts — executed with a mentor and coach model — immediately opens doors to learning within our clients’ organizations.
Our executive team hand selects each consultant on our project teams to meet the specific needs and the organizational challenges of every client, without exception.
This approach represents a winning strategy created specifically to establish and maintain alignment at all levels within our clients' organizations and internally across our consulting teams.
Although every project represents its own challenges, this formula has consistently proven to capture the magic, producing sustainable progress for our clients' organizations, regardless of the project type.
In fact, an average of 72 percent of the projects we complete are from return clients. These prior clients have selected QxP as their partner of choice for additional projects with varying scopes, scales, and strategic objectives.
We applied this same formula to our new flagship product — Virtuosi. Virtuosi is a comprehensive virtual reality educational platform serving the pharma, biotech, and advanced therapies industries. Our team of experts created this product to reduce human error, time to learning competency, time to market for new products, and employee turnover, while also improving drug supply and ensuring patient safety.
Understanding. A desire to learn. Organizational momentum. Sustainability. Collectively, they make the difference between success and failure. None are easily achieved without a purposeful and evolving strategy, fused with constantly aligned execution.

Crystal Mersh
CEO
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