Insights

Expert articles from project practice.

Articles, case studies and whitepapers, with regulatory references instead of buzzwords.

News & Updates

News25 Jun 2026

BayOConnect 2026: Regulatory Strategy Determines Biotech Success

Martina Schneider (CSL Innovation / LOVEDIS) and Lena Pauli-Tzschirner (Entourage) in a live interview on regulatory strategy and startup valuation at BayOConnect 2026 in Munich.

News11 May 2026

Biosimilar Medicines Conference Amsterdam 2026: SPC Extension, Biotech Act and What It Means for Manufacturers

Two days in Amsterdam, several contentious points: the Biosimilar Medicines Conference 2026 laid bare the current flashpoints of the biosimilar industry. One topic dominated the discussion: the planned extension of the supplementary protection certificate (SPC) in the Biotech Act and what it means for the market entry prospects of the next wave of biologics.

News8 May 2026

AI Compliance in the GMP Environment: Training with the Authors of the ISPE GAMP AI Guide

How can AI systems be operated in a valid and compliant way in GxP-regulated environments? In May 2026, Entourage hosted a deep-dive training in which two of Europe's leading experts on AI compliance explained regulatory practice directly from their work developing the ISPE GAMP standards.

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Analysis & knowledge

Articles & Whitepapers

Article18 Jun 2026

Computer System Validation: Two New Standards, One 12-Week Window

The revised Annex 11 is in final consultation. Annex 22 sits alongside it in draft: the EU's first dedicated guidance on AI in GMP manufacturing. Read them side by side and the message is the same. The bar for trusting a computerised system is moving up.

Article11 Jun 2026

AI-Driven Inventory Optimisation: Consolidating Redundant Stock Without Touching the ERP

In pharma and MedTech warehouses, duplicated, technically identical items tie up capital and space without showing up in the ERP. How feature-based consolidation with AI makes redundant stock visible, without any intervention in the validated system.

Whitepaper10 Jun 2026

MDR Meets the EU AI Act: The Trilemma for AI Software

AI software that qualifies as a medical device must satisfy the MDR and the EU AI Act at the same time. The costly mistake is not the second regulation, but running two separate worlds of documentation. Where MDR classification and AI Act high-risk status interlock.

Article2 Jun 2026

What manual visual inspection really costs

We fully costed a completed AVI project: 89 inspectors replaced by two automated systems, 4.2 million euro in annual savings, ROI in around 2.5 years.

Article2 Jun 2026

The EU AI Act for Life Sciences: When AI Counts as High-Risk

Whether AI in a medical device or IVD counts as high-risk AI is decided not by the technology but by the conformity assessment route under the MDR or IVDR. How Art. 6 of the EU AI Act triggers the classification and which application dates matter.

Article28 May 2026

CDMOs as Strategic Partners: From Capacity Provider to Co-Creator of Value

The pandemic has recalibrated the role of CDMOs. Those who only sell capacity remain interchangeable; those who bring together digitalisation, joint planning and resilience become strategic partners. The four building blocks of this transformation and what they mean for partner selection.

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Project examples

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Case Studies

Case Study

Annex 1 Compliance in Sterile Manufacturing

An international pharmaceutical company specializing in sterile products had to align its processes and systems with the new requirements of Annex 1 of the EU GMP Guidelines.

Case Study

Audit Software Integration for Improved Production Quality under GMP

An international software provider in the regulated life sciences environment needed a robust internal audit system to monitor production processes in line with GMP and reduce regulatory risk.

Case Study

Audit Support: Securing Reliable Audit Results

Provision of independent, experienced auditors to conduct audits to GMP and ISO standards, including report writing and CAPA follow-up.

Self-assessments

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Readiness Checks & Tools

Check6 questions

EUDAMED Readiness Check

6 questions, 3 minutes: how far along is your EUDAMED registration really, and where do typical gaps block you?

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Check3 questions

AI Act × MDR Trilemma Check

3 questions: does your AI software fall under the EU AI Act as a high-risk system, on top of MDR/IVDR?

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Check12 questions

EU AI Act Readiness Check

12 questions, 6 minutes: your AI is classified as high-risk, or you suspect it is. How far are your Art. 8-15 records really?

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Video library

Regulatory Update Hub

12 short expert videos on the MDR/IVDR revision, free after a one-time registration.

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