--- title: Blog | Regulatory Affairs description: Regulatory Affairs | Stay updated on Life Science through expert insights, industry trends, latest news and more with PQE Group's blog. --- [![Logo PQE Group - azzurro - 2024](https://blog.pqegroup.com/hs-fs/hubfs/Logo%20PQE%20Group%20-%20azzurro%20-%202024.png?width=2000&height=721&name=Logo%20PQE%20Group%20-%20azzurro%20-%202024.png "Logo PQE Group - azzurro - 2024")](https://www2.pqegroup.com) - [Home](https://www2.pqegroup.com/) - [Industry](https://www2.pqegroup.com/industry/) - [Pharma & API](https://www2.pqegroup.com/pharma-api/) - [Medical Device](https://www2.pqegroup.com/medical-device/) - [Biotech](https://www2.pqegroup.com/biotech/) - [Startup](https://www2.pqegroup.com/startup/) - [Veterinary](https://www2.pqegroup.com/veterinary/) - [Services](https://www2.pqegroup.com/services/) - [Data Integrity](https://www2.pqegroup.com/data-integrity/) - [Digital Governance](https://www2.pqegroup.com/digital-governance/) - [Engineering](https://www2.pqegroup.com/engineering/) - [Commissioning, Qualification and Validation (CQV)](https://www2.pqegroup.com/commissioning-qualification-validation/) - [Quality Compliance](https://www2.pqegroup.com/quality-compliance/) - [Laboratory Excellence](https://www2.pqegroup.com/laboratory-excellence/) - [Regulatory Affairs](https://www2.pqegroup.com/regulatory-affairs/) - [Audits](https://www2.pqegroup.com/audits/) - [Training](https://www2.pqegroup.com/training/) - [Clinical Research](https://www2.pqegroup.com/clinical-research-services/) - [Pharmacovigilance](https://www2.pqegroup.com/pharmacovigilance/) - About - [About Us](https://www2.pqegroup.com/about/) - [ESG](https://www2.pqegroup.com/about/csr/) - [Women in STEM](https://www2.pqegroup.com/about/women-in-stem/) - Resources - [News & Press](https://www2.pqegroup.com/news/) - [Webinars](https://www2.pqegroup.com/webinars/) - [Blog](https://blog.pqegroup.com/) - [Careers](https://www2.pqegroup.com/careers/) - [Contact Us](https://www2.pqegroup.com/contact-us/) [Home](https://www2.pqegroup.com/) [Blog](https://blog.pqegroup.com/) # **Latest Insights** [Regulatory Affairs ![](https://blog.pqegroup.com/hubfs/eCTD%20Regulatory%20Affairs_Blog.webp)](https://blog.pqegroup.com/regulatory-affairs/ectd-as-your-strategic-asset-rethinking-ectd-in-modern-regulatory-affairs) 06 Jul 2026 ## [eCTD as your strategic asset: Rethinking eCTD in Modern Regulatory Affairs Transform eCTD from a compliance requirement into a strategic asset. Learn how regulatory teams improve efficiency, reduce risk, and accelerate.](https://blog.pqegroup.com/regulatory-affairs/ectd-as-your-strategic-asset-rethinking-ectd-in-modern-regulatory-affairs) [![twitter](https://blog.pqegroup.com/hubfs/twitter-1.png)](https://twitter.com/intent/tweet?text=eCTD%20as%20your%20strategic%20asset:%20Rethinking%20eCTD%20in%20Modern%20Regulatory%20Affairs&url=https://blog.pqegroup.com/regulatory-affairs/ectd-as-your-strategic-asset-rethinking-ectd-in-modern-regulatory-affairs) [Regulatory Affairs ![](https://blog.pqegroup.com/hubfs/BANNER-USP%20Regulation%20-%20Plastic%20Contamination%20Risks%20and%20Single-Use%20Systems-1.jpg)](https://blog.pqegroup.com/regulatory-affairs/usp-665-1665-compliance-risk-assessment-for-biotech-and-api-manufacturing) 29 Apr 2026 ## [USP \<665\>/\<1665\> Compliance: Risk Assessment for Biotech & API Manufacturing USP \<665\> goes live in 2026. Are your polymer components compliant? Learn why early risk assessment is the key—and how to prepare.](https://blog.pqegroup.com/regulatory-affairs/usp-665-1665-compliance-risk-assessment-for-biotech-and-api-manufacturing) [![twitter](https://blog.pqegroup.com/hubfs/twitter-1.png)](https://twitter.com/intent/tweet?text=USP%20%3C665%3E/%3C1665%3E%20Compliance:%20Risk%20Assessment%20for%20Biotech%20&%20API%20Manufacturing&url=https://blog.pqegroup.com/regulatory-affairs/usp-665-1665-compliance-risk-assessment-for-biotech-and-api-manufacturing) [Regulatory Affairs ![](https://blog.pqegroup.com/hubfs/ICH%20M14_Blog_1-1.jpg)](https://blog.pqegroup.com/regulatory-affairs/a-harmonized-approach-to-non-interventional-studies) 20 Mar 2026 ## [ICH M14: A Harmonized Approach to Non Interventional Studies ICH M14 provides a global framework for non‑interventional studies using real‑world data, enhancing transparency, consistency, and methodological.](https://blog.pqegroup.com/regulatory-affairs/a-harmonized-approach-to-non-interventional-studies) [![twitter](https://blog.pqegroup.com/hubfs/twitter-1.png)](https://twitter.com/intent/tweet?text=ICH%20M14:%20A%20Harmonized%20Approach%20to%20Non%20Interventional%20Studies&url=https://blog.pqegroup.com/regulatory-affairs/a-harmonized-approach-to-non-interventional-studies) [Regulatory Affairs ![](https://blog.pqegroup.com/hubfs/ICH%20E6_Blog-1.jpg)](https://blog.pqegroup.com/regulatory-affairs/ich-e6r3-annex-2-key-changes-reflections-and-how-to-prepare) 04 Mar 2026 ## [ICH E6(R3) Annex 2: Key Changes, Reflections, and How to Prepare ICH E6(R3) Annex 2 reshapes GCP for decentralized and real-world data–driven trials.](https://blog.pqegroup.com/regulatory-affairs/ich-e6r3-annex-2-key-changes-reflections-and-how-to-prepare) [![twitter](https://blog.pqegroup.com/hubfs/twitter-1.png)](https://twitter.com/intent/tweet?text=ICH%20E6(R3)%20Annex%202:%20Key%20Changes,%20Reflections,%20and%20How%20to%20Prepare&url=https://blog.pqegroup.com/regulatory-affairs/ich-e6r3-annex-2-key-changes-reflections-and-how-to-prepare) [Regulatory Affairs ![](https://blog.pqegroup.com/hubfs/QMSR%20Transition%20FAQ_Blog.jpg)](https://blog.pqegroup.com/medical-device-regulatory/5-frequently-asked-questions-about-the-fdas-qmsr-final-rule-answered) 12 Feb 2026 ## [5 Frequently Asked Questions about the FDA’s QMSR Final Rule (Answered) FDA QMSR: practical answers to the most common industry questions.](https://blog.pqegroup.com/medical-device-regulatory/5-frequently-asked-questions-about-the-fdas-qmsr-final-rule-answered) [![twitter](https://blog.pqegroup.com/hubfs/twitter-1.png)](https://twitter.com/intent/tweet?text=5%20Frequently%20Asked%20Questions%20about%20the%20FDA’s%20QMSR%20Final%20Rule%20(Answered)&url=https://blog.pqegroup.com/medical-device-regulatory/5-frequently-asked-questions-about-the-fdas-qmsr-final-rule-answered) [Regulatory Affairs ![](https://blog.pqegroup.com/hubfs/QMSR%20Transition_Blog-1.webp)](https://blog.pqegroup.com/regulatory-affairs/fdas-quality-management-system-regulation-qmsr-final-rule) 27 Jan 2026 ## [FDA’s Quality Management System Regulation (QMSR) Final Rule The FDA QMSR Final Rule aligns 21 CFR 820 with ISO 13485:2016. Learn what changes and how medical device manufacturers should prepare.](https://blog.pqegroup.com/regulatory-affairs/fdas-quality-management-system-regulation-qmsr-final-rule) [![twitter](https://blog.pqegroup.com/hubfs/twitter-1.png)](https://twitter.com/intent/tweet?text=FDA’s%20Quality%20Management%20System%20Regulation%20(QMSR)%20Final%20Rule&url=https://blog.pqegroup.com/regulatory-affairs/fdas-quality-management-system-regulation-qmsr-final-rule) [Regulatory Affairs ![](https://blog.pqegroup.com/hubfs/IVDR%20Regulation_Banner%20new.jpg)](https://blog.pqegroup.com/regulatory-affairs/ivdr-what-does-it-mean-for-manufacturers-of-in-vitro-diagnostic-devices) 04 Mar 2025 ## [IVDR: What Does It Mean for Manufacturers of In Vitro Diagnostic Devices? The transition to IVDR introduces new challenges for IVD manufacturers, with stricter requirements and revised timelines to ensure compliance](https://blog.pqegroup.com/regulatory-affairs/ivdr-what-does-it-mean-for-manufacturers-of-in-vitro-diagnostic-devices) [![twitter](https://blog.pqegroup.com/hubfs/twitter-1.png)](https://twitter.com/intent/tweet?text=IVDR:%20What%20Does%20It%20Mean%20for%20Manufacturers%20of%20In%20Vitro%20Diagnostic%20Devices?&url=https://blog.pqegroup.com/regulatory-affairs/ivdr-what-does-it-mean-for-manufacturers-of-in-vitro-diagnostic-devices) [Regulatory Affairs ![](https://blog.pqegroup.com/hubfs/Medicines%20in%20Europe_Banner_1.jpg)](https://blog.pqegroup.com/regulatory-affairs-farmacovigilancia/medicines-in-europe-registration-lifecycle-management-and-extension) 23 Oct 2024 ## [Medicines in Europe: Registration, lifecycle Management and Extension Medicines in Europe need Marketing Authorization and ongoing safety monitoring to ensure compliance and patient safety.](https://blog.pqegroup.com/regulatory-affairs-farmacovigilancia/medicines-in-europe-registration-lifecycle-management-and-extension) [![twitter](https://blog.pqegroup.com/hubfs/twitter-1.png)](https://twitter.com/intent/tweet?text=Medicines%20in%20Europe:%20Registration,%20lifecycle%20Management%20and%20Extension&url=https://blog.pqegroup.com/regulatory-affairs-farmacovigilancia/medicines-in-europe-registration-lifecycle-management-and-extension) [Regulatory Affairs ![](https://blog.pqegroup.com/hubfs/New%20ICH%20Q2_Site%20Banner.jpg)](https://blog.pqegroup.com/ra-phv/new-ich-q2-r2-and-ich-q14) 05 Jun 2024 ## [New ICH Q2 (R2) and ICH Q14: a Step Forward Towards the Validation of Analytical Methods New ICH Q2 (R2) and ICH Q14 set to revolutionize analytical method validation in the pharmaceutical industry, enhancing quality, safety, and.](https://blog.pqegroup.com/ra-phv/new-ich-q2-r2-and-ich-q14) [![twitter](https://blog.pqegroup.com/hubfs/twitter-1.png)](https://twitter.com/intent/tweet?text=New%20ICH%20Q2%20(R2)%20and%20ICH%20Q14:%20a%20Step%20Forward%20Towards%20the%20Validation%20of%20Analytical%20Methods&url=https://blog.pqegroup.com/ra-phv/new-ich-q2-r2-and-ich-q14) [Regulatory Affairs ![](https://blog.pqegroup.com/hubfs/Vet%20GABA_1_Site%20Banner.jpg)](https://blog.pqegroup.com/ra-phv/clinical-and-pre-clinical-trials-for-veterinary-medicinal-products) 18 Mar 2024 ## [Clinical and Pre-clinical trials for Veterinary Medicinal Products Learn about the importance of clinical and pre-clinical trials for veterinary medicinal products, including regulatory requirements, study types, and.](https://blog.pqegroup.com/ra-phv/clinical-and-pre-clinical-trials-for-veterinary-medicinal-products) [![twitter](https://blog.pqegroup.com/hubfs/twitter-1.png)](https://twitter.com/intent/tweet?text=Clinical%20and%20Pre-clinical%20trials%20for%20Veterinary%20Medicinal%20Products&url=https://blog.pqegroup.com/ra-phv/clinical-and-pre-clinical-trials-for-veterinary-medicinal-products) [Load More](https://blog.pqegroup.com/tag/regulatory-affairs/page/2) ### Categories - 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