Driving LifeSciences into sustainable future.
PQE Group is an ISO 9001 certified technology solutions and compliance consulting services company with global capabilities deliverable throughout the entire product quality life cycle.
With offices located worldwide and a full-ranged broad service portfolio, extensive experience, effective project management, and exceptional cost effectiveness, PQE’s solutions are proven to be the winning combination for global corporations, as well as small and medium sized companies.
- Strong Quality Focus
- Flexibility & Dynamism
- Rapid Problem Solving
- Extensive Multidisciplinary Know-How
- Value for Money
- Multiculturality & Global Footprint
PQE at a glance
- Global Quality Solution Provider for our Customer’s GCP, GLP, GMP & GDP product development challenges since 1998.
- Hundreds of compliance solutions consultants, for rapidly and globally deploying flexible and well-organized project teams anywhere our clients require.
- Wide geographical coverage throughout Europe, North and South America, the Middle East, India, China and Japan, with more than 1500 employees operating worldwide, representing different nationalities and speaking more than 25 languages.
- International references from thousands of projects completed worldwide.
- Experience in working on regional and global projects and on rollouts for large corporations.
- Long history of supporting local leaders as well as small and medium companies in complying with FDA, EMA, ANVISA, WHO, GILS, COFEPRIS and other international, regional or local regulatory authorities.
- Proven methodology along with effective knowledge transfer mechanisms.
- Exceptional focus on cost effectiveness, while maintaining the highest quality standards.
- Internal instruments warehouse, with “project-ready” instrumentation for equipment validation and utilities qualification, equipped with traceable calibration certificates.
We dedicate our efforts to create value for our customers by putting our multidisciplinary teams, knowledge and competences in the Pharmaceutical and the Medical Devices industry at their service, allowing our clients to achieve and maintain Compliance with the latest regulations and contributing to create a safer pharmaceutical environment. Our aim is to help our customers to reach success expressing their business’ strategies and full potential on global and local markets. Our vision is to become market leaders as Solution Provider for Sustainable Compliance and a global reference as an ethical company.
Ethics-driven company, fostering Change.
Everyday at PQE Group, employees and managers work together at all levels to foster a positive change in community, environment, and in the LifeScience industry as well. To do so, we promote Corporate Responsibility, ethical behaviour, business practice and a culture based on respect of people and environment.
An Award-Winning Company
Italy Post - L'Economia
2018 - 2019 - 2020
2014 - 2018
Italian Osservatorio PMI
2018 - 2019
London Stock Exchange Group
Osservatorio Palazzo Montecitorio
CEO & Founder
« Since the foundation of PQE, I have strongly believed that our core values, know-how, people and ethics, can make PQE the market leader for sustainable compliance solutions in Europe and beyond. As a matter of fact, we are growing year by year thanks to a full time workforce of dedicated employees, which allows us to enhance our robust and standardized commitment to excellence.
Our passion for the growth and development of life science companies enables PQE to consistently exceed our customer’s expectations. This is the reason why we have successfully completed thousands of projects around the world, working in more than 20 different languages. »
Founder and CEO of PQE, Gilda D'Incerti graduated with a degree in Economic Statistics from the University of Bocconi in Milan, Italy. Gilda has worked extensively in the field of Information Technology and specifically, IT Compliance on both a national and international level for companies such as Siemens Data (Milan) and Edicon (Montreal). Before founding PQE in 1998, Gilda was the IT Manager for The Menarini Group's Spanish affiliate in Barcelona, following this, Gilda became the Operations Manager for F&J Systems Italy and ultimately an Executive Consultant in Validation for M.I.S. She is globally recognized as an international expert in the field of Computer System Validation and Data Integrity Assurance due to her broad spectrum of project experience. Certified Tick-IT and PDA Auditor, Gilda is nowadays a worldwide recognized Expert on Data Integrity providing war room support and strategic consultancy for clients in order to comply with the FDA and other regulatory bodies during critical inspections. Most recently, Gilda collaborated with COFEPRIS in Mexico and ANVISA in Brazil to set up Data Integrity rules and guidance. Gilda has trained on Data Integrity inspectors coming from several regulatory agencies. In 2021, Gilda D’Incerti entered the Forbes Business Council as she was vetted and selected by a review committee based on the depth and diversity of her experience. Criteria for acceptance include a track record of successfully impacting business growth metrics, as well as personal and professional achievements.
Meet our Management Team
Vice President Executive
Graduated with a degree in Physics and a PhD in Engineering.
Globally recognized as an expert in the fields of Data Integrity Assurance, Computer System Validation and Serialization, as well as PDA Certified Auditor and speaker at international seminars and events dedicated to Computer System Validation. 20+ years of experience in managing multi-site, international projects for MES, ERP and Serialization System Validation.
Member of PQE Board and Partner since 2004, exclusively managing the Service Design and Scientific Affairs department since 2014.
Vice President Sales
& Head of Subsidiaries
Graduated with a degree in Chemistry (Biological Molecules) at the University of Florence and PhD at University of Florence and Harvard Medical School of Boston, specialized in diagnostic test developments for early diagnosis of autoimmune diseases such as Multiple Sclerosis and Diabetes.
Robust expertise in managing international Computer System Validation and Data Integrity Assurance projects with a focus on 21CFR part 11 and EU GMP Annex 11 Compliance.
Partner and Member of the Board.
Vice President Strategic Planning
Graduated with a degree in Economics and Formerly financial auditor at Arthur Andersen, before moving into the Medical Device industry.
25+ years experience in large corporations such as Baxter, Pfizer and Sorin, helding roles in Finance (Controller, Director of Administration, Business Unit Planning & Control Director, CFO) and in Operations as Vice President Operations with responsibilities in manufacturing, logistics and R&D.
Ex Chairman of the Board at Erydel SpA, prior to joining PQE in 2010 as CFO, Partner and Member of the Board.
Vice President Technical Operation
Bertini has more than 20 years’ experience long career in Computerized Systems Validation and Data Integrity assurance. He graduated in Physics at the University of “La Sapienza” in Rome, and he joined PQE Group in 2000. During his time at PQE Group, he covered different roles in Europe and CIS Regions, where he has been leading the service delivery related to the Business Lines for Data Integrity Assurance. Today, Roberto is the Vice President of Technical Operations at global level and in his role he oversees all external projects and makes sure the quality standards are aligned while respecting the company methodology. He has managed the validation process of most common Computerized Systems used in the Life Science environment (e.g. ERP, MES, LIMS, WMS, Lab Systems, PCS, Serialization domain) and he has supported the implementation of Quality Management Systems for the IT governance. He is now supporting a number of pharmaceutical companies in the establishment of Data Integrity Governance and in the resulting Data Integrity Assessment and Remediations.
PMO Director & Partner
Simone Calò brings his expertise in PQE as project and program manager to bear on the challenges of change and growth. After graduating in Biomedical Engineering, Simone joined PQE as Validation Engineer. He has managed large and small C&Q, CSV and Data Integrity projects and programs that brought together members and stakeholders from multiple continents, time zones and cultures, by creating an environment of collaboration and trust to achieve successful project outcomes.
Since 2015 Simone has been a member of Operations Management where he cooperates with PQE Board, from 2018 is PQE Partner and currently serves as Global PMO Director managing interdisciplinary teams covering corporate key functions.
Founded in 1998, Rephine is a multinational audit and consultancy company that supports the pharmaceutical industry, focusing on GCP and GMP compliance, as well as regulatory matters. Headquarters are based in Stevenage, UK, with branch associates in India, Germany, Poland, France, Spain and Italy.
Rephine’s core business is its library of GMP Audit Reports which are available for customers to purchase instead of conducting their own audits at suppliers. The GMP library includes more than 200 GMP audit reports, covering 7,390 individual products, which makes Rephine the largest provider of third-party GMP audit reports in Europe.
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