Skip to content
Entourage

Expertise

Depth across the full spectrum

Five capability fields that interlock across the entire product lifecycle, for pharma, biotech, medtech and IVD.

Book an intro call →

Five capability fields

What we do.

Five capability areas that interlock across the entire product lifecycle, bookable individually, effective together. Each area is run by specialists who don't just advise but deliver, from first classification to post-market surveillance.

The product lifecycle

  1. 01

    Pre-Clinical

  2. 02

    Clinical

  3. 03

    Regulatory & Approval

  4. 04

    Launch

  5. 05

    Post-Launch

Our areas of expertise

In which area can we support you?

Product Development & Regulatory StrategyFrom classification and regulatory strategy through to development and study planning.
Software as a Medical DeviceClinical EvaluationDesign ControlsUsability Engineering+15
Market Access, RWE & ReimbursementMarket access, health economics, real-world evidence and pricing and reimbursement strategy.
Market Access StrategyPricing & ReimbursementHTA DossierReal-World Evidence+4
Regulatory AffairsApproval and conformity under MDR, IVDR and pharmaceutical law, from the technical documentation to the notified body.
MDR ConformityIVDR ReadinessEU AI ActEUDAMED+21
Quality Management & ComplianceQM systems, audits, computer system validation and data integrity under ISO 13485, GMP and 21 CFR Part 11.
Good Manufacturing Practice (GMP)Computer System Validation (CSV)GxP Audits (GMP, GLP, GCP)CAPA Management+20
Supply Chain & Technical OperationsSupply chain, manufacturing, shortage management and technical operations optimization.
Manufacturing & Supply Chain ManagementGood Distribution Practice.Production Transfer & Scale-UpDigitalization in Life Sciences+23

Why Entourage

One of the few consultancies with real depth across all four life sciences sectors.

15+

Years of industry experience in regulated markets

500+

Projects successfully completed

100%

Focus on life sciences

4

Offices: Munich, Basel, Milan, Boston

How we work

Three ways to engage.

Clarity before action.

Strategy Consulting

Market analyses, regulatory roadmaps and growth strategies in three phases: diagnosis, strategy development, pilot. Every strategy is validated before roll-out.

When clarity on strategy and priorities is missing: market entry, portfolio strategy, digitalization roadmap or regulatory realignment.

Your project. Our responsibility.

Project Consulting

Operational project ownership with permanently employed consultants, outcome-based rather than hourly: as a managed service, dedicated expert mandate or project package.

When capacity and expertise are missing: resource bottleneck, audit preparation or production ramp-up.

Think and do.

Hybrid Consulting

Strategic advice and operational delivery in the same project, from roadmap to go-live, without handover losses between the strategy and implementation phases.

When direction and delivery power are needed at once: transformations, approval projects, market entry.

All formats →

Insights

Latest insights.

All insights →
Insight

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.

ISPE GAMP 5 (2nd Edition, 2022)

Insight

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.

EU GMP Guidelines Annex 11 (Computerised Systems)

Case Studies

Projects we have completed.

All case studies →
Pharma

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.

-30% contamination risk

Pharma

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.

Compliance with GMP standards

A concrete project in this area?

Briefly outline your situation. We'll respond with an initial assessment, usually within one business day.

Book an intro call