About Us

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 more than 20 offices 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.

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Core Values
  • Strong Quality Focus
  • Innovation
  • Flexibility & Dynamism
  • Ambition
  • Reactivity
  • Ethics
Key Assets
  • Rapid Problem Solving
  • Transparency
  • Efficiency
  • Extensive Multidisciplinary Know-How
  • Value for Money
  • Multiculturality & Global Footprint

PQE at a glance

    Solutions
  • Global Quality Solution Provider for our Customer’s GCP, GLP, GMP & GDP product development challenges since 1998.
  • Teams
  • Hundreds of compliance solutions consultants, for rapidly and globally deploying flexible and well-organized project teams anywhere our clients require.
  • Worldwide
  • Wide geographical coverage with 20+ offices throughout Europe, North and South America, the Middle East, India, China and Japan, with 700+ employees operating worldwide, representing 45 different nationalities and speaking more than 25 languages.
  • Project
  • International references from thousands of projects completed worldwide.
  • Corporations
  • Experience in working on regional and global projects and on rollouts for large corporations.
  • Regulations
  • 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.
  • Mechanism
  • Proven methodology along with effective knowledge transfer mechanisms.
  • Effectivness
  • Exceptional focus on cost effectiveness, while maintaining the highest quality standards.
  • Tools
  • Internal instruments warehouse, with “project-ready” instrumentation for equipment validation and utilities qualification, equipped with traceable calibration certificates.

Our Mission

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.

Discover CSR

An Award-Winning Company

Top 1000 Fast Growing Companies in EU

Financial Times
2018

Top 10 Champion Companies in Italy

Italy Post - L'Economia
2018 - 2019

Best Supporting Partner Award

ISPE
2014 - 2018

Excellent Enterprises Award

Italian Osservatorio PMI
2018 - 2019

1000 Companies to inspire Europe

London Stock Exchange Group
2018

Top 30 Excellent Enterprise

Osservatorio Palazzo Montecitorio
2018

Gilda D'Incerti
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. »

Graduated with a degree in Economic Statistics from the University of Bocconi in Milan, Italy.
Formerly IT Manager for Menarini Group's Spanish affiliate in Barcelona and then Operations Manager for F&J Systems Italy and Validation Executive Consultant for M.I.S.
Globally recognized as an international expert in the field of Computer System Validation and Data Integrity Assurance as well as Certified Tick-IT and PDA Auditor. Collaborator of Cofepris in Mexico for the creation of the new documents for Mexican GMP guidelines.

Meet our Management Team
Claudio Puglisi
Vice President & COO

Graduated with a Master Degree in Pharmaceutical Chemistry. 20+ years of increasing responsibility roles in international pharmaceutical firms. Huge experience in manufacturing and quality of sterile products and in management of facilities specialized in contract manufacturing for the main worldwide markets. Member of the PDA since 1998 and Program Planning Committee Member, Speaker and Session Moderator in several International Meetings. Pointed out as part of the PDA Executive Committee as Italy Chapter Liaison and External Relationship in 2019.

Danilo Neri
Vice President Operations

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.

Paolo Benatti
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.

Stefano Carganico
Global Sales Director & Partner

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.

Partnerships
Rephine LTD

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.

BAI Partners

BAI Partners offers a wide range of manufacturing and quality management services, focusing in the two main areas of Change Management and Transitional Leadership, supporting businesses in effectively changing direction to improve product quality and compliance, efficiency and business results.
In addition, BAI Partners supports the development of strategic partnerships with CMOs, including due diligence evaluation and FDA readiness auditing and other various Specialty Projects. Based in Princeton, NJ (U.S.A), with an EU branch associate in Germany.

Want to know more?

Get in touch with our team and read about our worldwide locations.
We will be happy to find the most suitable solution for your Business.

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