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Founded in 1998, PQE Group is a women owned consulting company operating in Lifesciences. Since 2012 the CEO & Founder of the group, Gilda D’Incerti, has opened 28 offices worldwide, developing a network of contacts at international level.
Certified ISO 9001 since March 2003, PQE has been characterized as Complete Quality Solutions Provider for companies operating both nationally and internationally. It currently has more than 1500 employees distributed in the operational offices in Italy, Germany, Spain, France, Switzerland, UK, Belgium, Poland, Russia, Israel, USA, Mexico, Brazil, Argentina, India, China and Japan.
As an international workforce, the consultants at PQE Group have experience in working in over 25 languages and have an excellent history of supporting small, medium and large size companies exceeding compliance standards from the FDA / EMA / WHO / TGA / SFDA / ANVISA / INVIMA / GILS and other local authorities.
PQE Group offers turnkey quality solutions and focuses on offering exceptional cost effectiveness, whilst maintaining highest quality standards for its Clients.
Combining the high knowledge acquired in the fields of Processes, Information Technology, Engineering and Quality, PQE Group supports its clients in both Pharmaceutical and Medical Device fields in the following areas:
• Data Integrity Assurance
• Computer System Validation
• Digital Governance
• Qualification of laboratory process equipment and utilities
• GxP Compliance
• Laboratory Excellence
• Regulatory Affairs & Pharmacovigilance
• Qualification & Engineering
• Auditing
• Training
Year of establishment:
1999
Number of employees:
MORE THAN 499 EMPLOYEES
Annual turnover:
over 25 milion Euro
Reference year of turnover:
2021
Export turnover:
0
Activities:
Other service activities related to information technology nec
Entrepreneurial consultancy and other administrative-management consultancy
Trial research and development in the bio-technological field
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Gilda D'Incerti founded PQE Group in 1998 with a clear vision: invest in people, diversity and ethic. Being a quality expert in the Life Science industry means to think about the well being of all of us as consumer.
PQE Group is among the winners of the fourth edition of the "Best Managed Companies" Award, an initiative promoted by Deloitte Private to support and reward Italian business excellence within the initiative supported by ELITE - the Borsa Italiana program that supports the development and growth of high-potential companies -, by Confindustria and by ALTIS Università Cattolica. The award confirms that the processes put in place by PQE, even internally, have been successful: from the Teal organization, to CSR projects, all while always putting the human resource at the center.
Pharmaceutical industry is currently producing significant amounts of electronic data through manufacturing lines increasingly automated via pervasive sensors and devices. Manufacturing line data sources are heterogeneous with various embedded systems controlling the different processes involved in the production of medicines. The main idea of this project is to systematically assess all data produced by computerized production systems in representative pharma environments.
Find out more about the risks that might occur in your business because of data integrity related challenges. Our Vice President Danilo Neri can help you understand the key steps of how we can easily support your company in achieving compliance.
Check out the Q&A Session from Luisa Cabria, MD Compliance and RA Director at PQE Group, with 8 topics about the new MDR for Europe and make sure your business achieve compliance standards.
PQE Group - Service Catalogue
PQE Group - Company Profile
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- Business Proposals
Company:
PHARMA QUALITY EUROPE S.R.L.
Telephone:
+39 055 5275100
Web site:
Address:
LOC LOCALITA' PRULLI 103/C
City:
REGGELLO (FI)
Zip Code:
50066
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Data Integrity Assurance
Data is a fundamental part of any Life Science production cycle and has become a major concern for global regulatory authorities. Choose PQE and ensure patient safety and business continuity within the entire product life cycle.
A number of hidden potential violations may already be embedded in your current processes.
Don’t risk losing quality and trust: choose the right training, guidance and support.
-Assess and evaluate risks
-Validate your system
-Avoid observations and enforcements actions
-Prevent impacts on business operations
-Ensure that all data is compliant to the newest regulations
-Achieve growth and success
PQE Group, with multidisciplinary teams with 20+ years of extensive experience and scalable delivery model based on a robust risk analysis, has an unmatched record of supporting clients in turnkey validation projects with FDA, EMA, WHO, COFEPRIS, GILS, TGA, SSA, SFDA, ANVISA, INVIMA and other regulatory authorities.
We can support you in every phase of the product lifecycle, assuring Data Integrity throughout all steps of the process, from Clinical Trials to Pharmacovigilance.
Digital Governance
With new advanced technologies and new standards for Compliance and Cybersecurity, developing an intelligent network and infrastructure is a top level priority for Life Science businesses. Choose PQE Group’s all-in-one integrated solutions to coordinate your Corporate Digital Development.
Here is why you should choose PQE Group as your compliance and quality service provider.
-Teams of qualified IT experts
-Proven knowledge in new technologies
-Familiarity with suppliers and manufacturing best practices
-Supporting Pharmaceutical and Medical Device firms
-Fully customizable IT service models
-Cost-effective solutions
The Life Science industry is evolving fast.
We developed our Advanced Remote Technologies to help your business reach its fullest potential.
Discover today the smartest assets to keep up and enhance your quality system:
-Perform virtual audits
-Get access to augmented reality technologies
-Validate systems remotely
-Transform your paper records in electronic data
-Cut distances, costs and risks
Quality Compliance
For Life Science businesses in highly regulated environments, compliance is not an option. Prepare to successfully pass inspections and design post-inspections remediation plans to achieve and maintain approval for your product with PQE Group's tailored and cost-effective programs for Quality Management.
Lack of inspection readiness or failed attempts at post-inspection remediations may lead to huge operating and legal costs like warning letters, product recalls, withdrawals and sanctions. Don’t risk losing quality and trust: choose the right training, guidance and support.
-Prepare for FDA, EMA and other authorities’ inspections
-Review documentation and records
-Identify gaps and take remedial actions
-Execute mock inspections and CAPA
-Achieve total control over production and processes
-Benefit from outsourced Quality Assurance support
-Enhance resources’ competences and behavior
Web site
https://www.pqegroup.com/compliance/
Qualification & Engineering
The act of Validation, originally addressed only to sterilized equipment, now involves all product, process and facility matters.
Choose PQE's solutions to ensure that your plant site meets your business objectives while being fully compliant with the latest Good Manufacturing Practice regulations and standards.
Every tool used in the manufacturing process has a high impact on product quality.
Don’t risk losing quality and trust: choose the right training, guidance and support.
-Validate procedures, materials, equipments and systems
-Establish a consistent product delivery
-Prove with documented evidence the reliability of the processes
-Avoid reject, reworks and down time
-Ensure compliance with regulatory authorities' standards
-Achieve growth and success
Regulatory Affairs
The field of RA encompasses all the work necessary to manage products’ registrations and to receive and maintain marketing authorization.
Choose PQE Group’s comprehensive support and broad strategic knowledge to launch products without delays and keep them on different worldwide markets.
To successfully comply with regulatory requirements and avoid penalties, rejects and delays, Life Science businesses need to be aware of the challenges posed by different laws operating in different market regions. Don’t risk losing quality and trust: choose the right training, guidance and support.
-Manage products’ approval and registration
-Speed up products’ launch
-Reach different countries and assure global coverage
-Keep products on the market consistently
-Coach R&D to collect the right data from the first stages
-Improve and standardize regulatory processes
A roadmap to EU MDR
PQE Group offers a specific regulatory support to any MD businesses looking to launch on the European market, needing guidance with CE Markings or wanting to ensure business continuity and renewal.
Book your first assessment with our team of experts and set up a time-tested strategic action plan to effectively and competitively manage regulatory compliance.