About us


We Support You Globally, Thinking Locally.

VISION

  • Think Business: Invest in Knowledge, People, and Ethics

MISSION

  • Become market leader as solution provider for sustainable compliance.

CORE VALUES

  • Quality oriented
  • Innovative
  • Flexible & Dynamic
  • Ambitious
  • Fast
  • Ethical

KEY ASSETS

  • Rapid Problem Solving
  • Transparency
  • Efficiency
  • Know How
  • Value for Money
  • Multiculturality & Global Footprint

Who is PQE

We are a ISO 9001 certified technology solutions and compliance consulting services company with global capabilities deliverable throughout the entire product quality life cycle, allowing us to offer services at a very competitive price.

Why PQE

Our broad service portfolio, extensive experience, effective project management, and exceptional cost effectiveness, have already proven to be a winning combination for global corporations, as well as small and medium sized companies.


PQE at a glance

  • Quality and Compliance Solutions Provider – Complete Quality Solution Provider for our Customer’s GCP, GLP, GMP & GDP product development challenges since 1998.
  • Hundreds of compliance solutions consultants on staff, enabling rapid global deployment of flexible, well-organized project teams anywhere our clients require.
  • Wide geographical coverage – offices throughout Europe and North and South America, the Middle East, India and China.
  • International references from thousands projects completed worldwide.
  • Experts fluent in more than 25 languages.
  • Experience in working on regional/global projects and rollouts for large corporations.
  • Long history of supporting local leaders and small/medium companies in reaching, FDA / EMA / ANVISA / WHO / GILS and other international, regional and local regulatory compliance 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 “ equipment validation & utilities qualification instrumentation with traceable calibration certificates.

Message from the C.E.O.

Gilda D’Incerti

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. Come discover what our customers have experienced.

Globally Awarded Company

Top 1000 Fast Growing Companies in EE.UU (Financial Times)

Top 1000 Fast Growing Europe Financial Times
Top 10 Champion Companies in Italy (Italy Post - L'Economia)

TOP 10 Champion Companies l'Economia Corriere della Sera
Top 100 Eccellenze Italiane (Obs. Palazzo Montecitorio)

100 Eccellenze Italiane Montecitorio
Excellent Enterprise (Italian "Osservatorio PMI 2018")

100 Eccellenze Italiane Montecitorio

Our Management Team

Gilda D'Incerti


Chief Executive Officer & Founder

Founder and CEO of PQE. 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 and Certified Tick-IT and PDA Auditor. Collaborator of Cofepris in Mexico (creation of the new documents for Mexican GMP guidelines).


Paolo Benatti


Vice President Strategic Planning

Graduated with a degree in Economics. 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 (VP Operations) with responsibilities in the areas of 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.


Claudio Puglisi


Chief Operating Officer & Vice President

Graduated with a Master Degree in Pharmaceutical Chemistry , Claudio has covered for 24 years roles of increasing responsibility in international pharmaceutical firms. He has a huge experience in manufacturing and quality of the sterile products and he managed facilities specialized in contract manufacturing for the main worldwide markets. Claudio is member of the PDA since 1998 and has served as Program Planning Committee Member, Speaker and Session Moderator in several International Meetings. In 2019 he has been pointed out as part of the PDA Executive Committee as Italy Chapter Liaison and External Relationship.

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, and 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 the Board of PQE, and Partner since 2004, exclusively managing the Service Design and Scientific Affairs department since 2014.

Stefano Carganico


P.M.O. Director

Graduated with a degree in Chemistry (Biological Molecules) at University of Florence, then with Ph.D at University of Florence and Harvard Medical School of Boston, specializing 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.