Articles
Practical insight from the people who do the work. Our articles unpack the regulatory, audit, and quality questions facing pharma, biotech, MedTech, and IVD teams, from GxP and FDA inspections to pharmacovigilance and EU MDR, with guidance you can actually put to use.
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GxP Compliance Explained: Beyond Best Practice
Understanding the meaning of GxP is essential for any organization operating in the life sciences sector. In…
QSIT vs QMSR: FDA’s New Medical Device Inspection Framework Explained
For more than two decades, the Quality System Inspection Technique – known universally in the medical device…
FDA Mock Inspections: Types, Common Findings and How to Prepare
Not every FDA mock inspection looks the same. The discipline a regulator will scrutinize, and the questions…
The Software Bill of Materials (SBOM): What Every SaMD Manufacturer Needs to Know
Regulatory Guide | FDA Cybersecurity | SaMD Compliance | QMSR | SBOM 2026 If you are developing…
Pharmacovigilance Data Protection in the EEA: A Compliance Guide to GVP VI Addendum II and GDPR (Part 1 of 3)
GDPR meets pharmacovigilance: what EMA’s new masking guidance means for your safety database | Apotech Consulting Pharmacovigilance…
Pharmacovigilance Data Protection in the EEA: A Compliance Guide to GVP VI Addendum II and GDPR (Part 2 of 3)
Transferring ICSRs to non-EEA countries: are your SDEAs still fit for purpose? | Apotech Consulting Pharmacovigilance ·…
Pharmacovigilance Data Protection in the EEA: A Compliance Guide to GVP VI Addendum II and GDPR (Part 3 of 3)
The L2A vs L2B download problem: what MAHs get wrong about EudraVigilance data sharing | Apotech Consulting…
GCP, GLP, and GMP: A guide to GxP compliance in life sciences
If your time is short If you work in pharmaceutical, biotech, MedTech, or in vitro diagnostic development,…
What is a GMP Audit? A Complete Guide For Regulated Industries
If your time is short The GMP audit is among the most critical checks on your company’s…
Pharmacovigilance Data Protection in the EEA: A Compliance Guide to GVP VI Addendum II and GDPR
Practical compliance guidance for QPPVs and PV teams on GVP VI Addendum II ICSR masking, GDPR international data transfers, and EudraVigilance L2A/L2B obligations.
Finding the Right Quality Assurance (QA) Consultants in Life Sciences
Written by Connie Prince – Talent Acquisition Manager Life sciences organizations increasingly rely on Quality Assurance (QA)…