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Articles

At Apotech, we are fully aware that the patient is the ultimate stakeholder of our projects, so we are dedicated to meeting all of our customer’s requirements.

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Apotech ALCOA+ principles diagram

ALCOA+ Principles in Pharma: The Next-Gen Standard for Data Integrity 

ALCOA+ and the modern data integrity landscape  Data integrity underpins regulatory compliance and patient safety. And as…

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Celebrating Global Partnerships: Apotech Consulting Expands to South Korea Partnering With Consulting BARO Inc.

At Apotech Consulting, international coverage has been part of our DNA since day one. Our mission has…

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2024 Pharmaceutical Inspections: Risk-Based, Remote-Ready, and Globally Harmonized

Staying audit-ready is no longer optional, it’s strategic! Based on EFPIA’s 2024 Inspection Survey, pharmaceutical manufacturers must…

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How to Make Sure Your CAPA Process Actually Works?

By Imane Nohair, GxP Audit manager at Apotech If you work in quality management, you know how…

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From Audit Non-Conformities to CAPA: A Systematic Approach

By Imane Nohair, GxP Audit manager at Apotech An organized method from audit non-conformities to CAPA overview…

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The 5 CAPA Metrics Every Quality Team Should Track

By Imane Nohair, GxP Audit manager at Apotech Corrective and Preventive Actions (CAPAs) are fundamental to quality…

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How To Master Your CAPA Process: From Identification to Implementation

By Imane Nohair, GxP Audit manager at Apotech The Importance of CAPA in the Pharmaceutical Industry: The…

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Get ready for Pharmaceutical Audits 2.0: How Technology Is Having An Impac

By Imane Nohair, GxP Audit manager at Apotech Introduction In the highly regulated pharmaceutical industry, audit readiness…

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December 2024 Newsletter

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Notified Bodies, Approved Bodies & Certification Bodies: Differences?

Notified Bodies A Notified Body is an organisation designated and authorised by an EU member state to…

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Navigating the Future of Laboratory Developed Tests (LDTs)

Laboratory Developed Tests (LDTs) have long been an essential part of diagnostic healthcare in the USA empowering…

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Contact us today to find out how we can support you in your next project.

Are you searching for bespoke, flexible outsourced services for your Biotech or MedTech projects? Apotech offer a comprehensive range of consulting services for biologics, medical devices and other pharmaceutical products. Our extensive team of Regulatory, Quality and Engineering Consultants provide a world-class service to clients, large and small.