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Life sciences consulting for quality, regulatory and operations.

Five practice areas, from product development through regulatory affairs and quality to supply chain and market access, for pharma, biotech, medical devices and IVD. One permanent team that delivers on the regulatory and operational side.

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Strategic advisory by situation

Why Entourage

Since 2013

Consulting in regulated markets

500+

Projects successfully completed

100%

Focus on life sciences

4

Locations: Munich, Basel, Milan, Boston

Strategic advisory

What is coming up for you?

One click on your situation leads to the path with its stages or to the matching area of expertise.

All projects in strategic advisory →

Services

We guide your product through every phase, without a break.

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.

From Pre-Clinical through Clinical and Regulatory & Approval to Launch and Post-Launch, without a break.

Product Development & Regulatory StrategyFrom classification and regulatory strategy through to development and study planning.
Market Access, RWE & ReimbursementMarket access, health economics, real-world evidence and pricing and reimbursement strategy.
Regulatory AffairsApproval and conformity under MDR, IVDR and pharmaceutical law, from the technical documentation to the notified body.
Quality Management & ComplianceQM systems, audits, computer system validation and data integrity under ISO 13485, GMP and 21 CFR Part 11.
Supply Chain & Technical OperationsSupply chain, manufacturing, shortage management and technical operations optimization.
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How we work

Consulting in the format that fits your task.

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Strategy Consulting

Clarity before action.

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

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Hybrid Consulting

Think and do.

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

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Operational Consulting

Your project. Our responsibility.

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

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Insights

Latest insights.

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Insight

PPWR: Why Pharma Packaging Is Not Exempt

"Pharma is exempt from PPWR" is only partly true. The Article 6(11) exemption covers primary packaging, and cartons only where they preserve product quality. The rest is in scope. General application: August 12, 2026.

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Insight

Hazard and Risk Analysis: Which Method Answers Which Question

PHA, FTA, ETA, FMEA, HAZOP and HACCP each answer a different question, and none of them produces a finished risk analysis on its own. This whitepaper sets out what each method is good for, how to choose between them and what a robust interface to the ISO 14971 risk analysis has to do.

ISO 14971:2019

Insight

Regulatory Intelligence: Not the Best Tool, but the Right Fit

When selecting a regulatory intelligence solution, success depends on the fit with your own regulatory context. Why feature lists are misleading and which four dimensions actually decide the outcome.

Regulation (EU) 2017/745 (MDR)

Case Studies

Selected projects

How we solve complex regulatory and operational challenges together with our clients.

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AVI Implementation: 89 Manual Inspectors to 2 Machines

€4.2M annual savings

A sterile fill-finish facility ran 89 manual visual inspectors on a single production line. The question was not whether to automate, but how to validate the transition in a GMP environment without disrupting the inspection track record.

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Improving Overall Supply Chain Effectiveness at a Medical Device Manufacturer

+30% delivery planning

Optimizing overall supply chain effectiveness at a medical device manufacturer, from demand planning and supplier management through to inventory control.

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Post-Merger Integration of a Diagnostics Manufacturer: 25 Percent COGS Reduction

25% COGS reduction

Following a strategic acquisition, a diagnostics manufacturer had to integrate operations, stabilize manufacturing and quality control, and close digital and regulatory gaps to protect cost of goods sold and accelerate time to market.

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Regulatory updates

Stay on top of regulatory change.

Two free resources that put new requirements on your radar early.

Regulatory Update Hub

19 short expert videos and 2 whitepapers on the MDR/IVDR revision. Free registration, access sent by email.

Visit the Regulatory Hub →

Life Science Journal

New requirements, authority decisions and practice notes. Once a month, unsubscribe any time.

Subscribe →

Events

Where to meet us

All events →

Trade fairs we attend as participants and where we take meeting requests, plus our own training sessions and webinars our experts speak at. A short message is enough and we will agree on a slot.

FAQ

Frequently asked questions

Pharma, biotech, medical devices and IVD, across the entire product lifecycle, from first classification to post-market.

Image notice: The images on this page were generated using artificial intelligence. They do not depict real people, places, or events.

Let's talk about your project.

Briefly outline your industry, topic and timeline. We'll respond with an initial assessment, usually within one business day.

Prefer direct? +49 89 4161170-0
info@theentourage.de

  • Munich (Headquarters)
  • Basel
  • Milan
  • Boston, MA
  • Reply usually within one working day
  • 4 locations: DE · CH · IT · US
  • 100% life sciences