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PQE Group

PQE Group

Consulenza e servizi aziendali

Reggello, FI 231.858 follower

Quality Solutions & Compliance Consulting | 25+ Years of Global Expertise supporting the Life Sciences Industry

Chi siamo

WHO WE ARE PQE Group is a women-owned, ISO 9001 certified technology solutions and compliance consulting Services Company, offering complete quality solutions for GCP, GLP, GMP, GVP, and GDP areas in the Life Science industry. With over 2,000 employees (40% of whom are women) across 45+ offices globally, we bring together 50+ nationalities and operate in 25+ languages. We are dedicated to creating value for our customers by leveraging our multidisciplinary teams and expertise, enabling them to achieve and maintain compliance with the latest regulations. WHAT WE DO Since 1998, PQE Group has been delivering turnkey quality solutions across the entire product quality lifecycle, focusing on offering cost-effectiveness without compromising quality. Our broad service portfolio and extensive experience have made us the trusted partner for global corporations, as well as small and medium-sized enterprises. To date, we have completed over 25,000 projects worldwide for 1,400+ clients in the pharmaceutical, medical device, SaMD, biotech, veterinary and other life science related sub-industries. WHY US? Our proven combination of expertise in project management, wide-ranging services, and exceptional cost-effectiveness makes PQE Group a valuable partner for businesses of all sizes. We help our clients achieve compliance, ensuring that our solutions drive success. WHERE WE’RE GOING At PQE Group, we are committed to fostering positive change in the communities and environments where we operate. Through our corporate social responsibility goals, we promote sustainable development, gender equality, environmental protection, and health and safety initiatives. Our partnerships with programs and charity organizations globally reflect our dedication to driving social and environmental impact.

Sito Web
http://www2.pqegroup.com
Settore
Consulenza e servizi aziendali
Dimensioni dell’azienda
1001 - 5000 dipendenti
Sede principale
Reggello, FI
Tipo
Società privata non quotata
Data di fondazione
1998
Settori di competenza
GAMP, CSV, Validation, Compliance, Qualification, Regulatory Affairs, Engineering, 21 CFR Part 11, Pharmaceutical, Medical Devices, Biotech, Life Sciences, Quality, Audit, SAP, GDPR, Data Integrity, Digital Governance, Cybersecurity, Serialization, IT, IT Infrastructure e Marketing

Località

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Aggiornamenti

  • Visualizza la pagina dell’organizzazione PQE Group

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    Our lives wouldn’t be complete without these adorable beings, that’s why we want you to join us this International Cat Day in showing them the love they deserve. The 8th of August is more than just an annual observation for us cat lovers, it’s a reminder of how lucky we are to have these feline friends who add comfort and companionship to our lives. Whether you’re a pet parent or someone who simply adores these “purrrfect😸” creatures, today is your day too, and let’s celebrate it by showing our cats how much they mean to us with a few extra treats and cuddles. The health and well-being of cats and all our animals means everything to us, that is why, as PQE Group, we continue to invest our expertise and resources into the veterinary medicine sector to support the production of quality, safe animal treatments worldwide. Happy 8th of August from all of us! 🐾 Explore our veterinary solutions – where compliance meets care: https://hubs.ly/Q03BV4Z90 #InternationalCatDay #VeterinaryCare #AnimalWellbeing #PQEGroup #QualityAndCompliance

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    AI is evolving fast and we have already started seeing how it can transform pharmaceutical operations and the way we approach scientific research. There is no doubt that pharmaceutical companies that adopt AI today not as a tool but as a core part of their strategy will gain a long-lasting competitive edge. But, while most of the industry's coverage on AI has focused on the benefits, it is only right we also highlight the cybersecurity risks ⚠️ that arise with the reliance on digital systems in the age of AI. Pharmaceutical companies have always been among the prime targets of cybercrimes, and while this is not news, the way cyber attackers have evolved with AI is. AI-assisted cyber attacks and malware have made traditional cybersecurity defenses obsolete, as these new cyber threats can adapt and continue operating under the radar, making them harder to detect. Read our latest article to learn more about the opportunities and challenges AI brings to the pharmaceutical industry and why pharmaceutical companies can no longer afford to postpone the AI paradox conversation. We would like to extend our sincere thanks to Danilo Maruccia and Gianluca Costa for their valuable contributions to this work. Their expertise and perspective were instrumental in shaping the discussion. Get the full article here 👉 https://hubs.ly/Q03BKQxs0 #AIinPharma #Cybersecurity #PharmaceuticalInnovation #DigitalTransformation #AIEthics #HealthTech

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    The European pharmaceutical market is one of the most lucrative and highly sought after regions in the world, providing manufacturers with both access to a large, high-value patient population and the prestige of meeting world-class regulatory standards. However, bringing a new pharmaceutical product to this region often means navigating a maze of complex regulatory procedures and fulfilling compliance and time-consuming documentation requirements, which are often challenging for even the most experienced teams. To help industry professionals overcome these challenges, PQE Group and Qualistery are teaming up once again for a second joint webinar highlighting the key steps and requirements to get your pharmaceutical products successfully registered in the EU. What You Will Gain by Attending: 1️⃣ A clear understanding of the main EU marketing authorization procedures 2️⃣ Insight into the essential components of the Common Technical Document (CTD) 3️⃣ Awareness of the pharmacovigilance system requirements necessary for successful product registration 4️⃣ A detailed overview of regulatory expectations regarding Chemistry, Manufacturing, and Controls (CMC), as well as non-clinical and clinical data 5️⃣ Practical guidance to plan timelines and allocate resources effectively for a smooth EU registration process 6️⃣ Knowledge of post-marketing obligations and how to manage variation procedures efficiently Register now to secure your spot 👉: https://lnkd.in/g76XPvNh

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    🏖️ Cybersecurity under the beach umbrella? Absolutely. Summer is the perfect time to unplug - but not from digital safety. Cybercriminals don’t take vacations, and even a quick check of your email on public Wi-Fi could put your data at risk. From securing your devices to avoiding risky networks, here are 7 essential tips to protect your digital life while enjoying your holiday. ☀️🌐 👇 Read the full article and travel smarter this summer. #CyberSecurity #DigitalSafety #VacationTips #InfoSecurity #SummerCyberTips #RemoteWork

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    In a recent interview with BioBuzz, Melinda Sogo, a Senior Medical Device Consultant at PQE Group, shared her journey and experience in the medical device industry, and how she has navigated its challenges while contributing to global regulatory advancements. When asked about how she continues to overcome challenges in the life sciences and deliver solutions for clients, Melinda credits her unique approach to problem solving, which involves carefully analyzing all the available information to identify exactly what the client needs, even when those needs are not immediately clear. Read the full article to learn why she has taken this approach to problem solving and what she has learned at PQE 👇 https://lnkd.in/e7K6H5R4 #MedicalDevices #LifeSciences #RegulatoryAffairs #ProblemSolving #WomenInSTEM #PQEGroup

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    🚨 Windows 10 support is coming to an end in just 2 months! Have you started preparing your migration strategy yet? Microsoft will officially end support for Windows 10 on October 14, 2025, marking the final chapter for one of the most widely used operating systems worldwide. After this date, Windows 10 will no longer receive security updates or technical support, putting your systems at risk. For organizations in the life sciences sector still running Windows 10, time is running out to ensure your computer systems remain secure , compliant with industry regulations, and protected against evolving cyber threats. Delaying migration could lead to operational disruptions, data breaches. and increased scrutiny from regulatory bodies. If you haven’t started your migration to Windows 11 yet, or you’re planning to complete it before the deadline, now is the time to act! 💡 Our latest article breaks down the best practices, key considerations, and a step-by-step action plan to help you transition smoothly and confidently. Don’t wait until it’s too late—stay ahead of the curve and safeguard your critical infrastructure and valuable data. Check out the full guide here 👇 and start planning your move today! https://hubs.ly/Q03zHPHR0 #Windows10 #Windows11 #Migration #CyberSecurity #LifeSciences #ITCompliance

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    🌟 We’re proud to announce that PQE Group has been awarded the Legality Rating by the Italian Competition Authority (AGCM)! This important recognition highlights our ongoing commitment to transparency, fairness, integrity, and corporate responsibility. It’s a milestone that reflects the values we live by and strengthens our credibility in the market. 👏 A sincere thank you to all our colleagues whose dedication made this achievement possible. Together, we continue to build a company that does things the right way. #PQEGroup #LegalityRating #AGCM #Compliance #Transparency #CorporateResponsibility #EthicsInBusiness #Teamwork #Integrity

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    From Hyderabad at the PDA India Chapter Meeting, PQE Group stands alongside industry leaders to help shape what’s next in pharma. We're discussing critical topics - from contamination control and aseptic processing to FDA 483 responses and the role of AI in pharma - all with a focus on innovation, compliance, and quality. 📍 Stop by tabletop #7 to connect with our team and learn more about how PQE Group is helping drive meaningful change in life sciences. #PQEGroup #PDAIndia2025 #PharmaInnovation #GMPCompliance #LifeSciencesIndia #QualityInPharma

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  • Visualizza la pagina dell’organizzazione PQE Group

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    Danilo Maruccia presents an overview of the revised Annex 11- a turning point for GMP compliance in the digital age. 🎯 Annex 11 is being redefined. Are you ready? The EU’s revised draft introduces expanded scope, sharper obligations, and a clear shift in mindset: from traditional validation to proactive digital asset management. From AI and cloud oversight to data integrity and cybersecurity, the new Annex demands full accountability and continuous system control. 🕒 The consultation period is open until October 7, 2025 - now is the time to assess your systems, partners, and compliance strategy. At PQE Group, we’ve been global leaders in GMP and Data Integrity since 1998 - supporting life science companies through every regulatory evolution. Watch this overview by Danilo Maruccia to discover the key changes and how to stay ahead. #DaniloMaruccia #Annex11 #GMP #PharmaCompliance #DataIntegrity #DigitalTransformation #PQEGroup #LifeSciences #CloudCompliance #AIinPharma

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    Rafael Ruiz Espinal, a Validation Engineer / CSV CSA & Data Integrity Specialist and consultant at PQE Group, has spent the last 7 years of his career in the life sciences industry developing the key skills needed to thrive in one of the most fast-paced and demanding sectors in the world. 🧪💼 Although Rafael has learned a lot over the years, learning to approach each project as a unique challenge rather than relying on a one-size-fits-all mindset has been one of the most important lessons he has gained in his journey as a consultant. 💡 #LifeSciences #ValidationEngineer #CSV #DataIntegrity #PQEGroup #PharmaIndustry #ConsultingLife

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