Skip to content
Entourage

Life Sciences Consulting

One partner across the entire lifecycle. Consulting that delivers.

Instead of separate specialist firms for each phase, one permanent team that delivers on the regulatory and operational side, from first classification to post-market surveillance.

Book an intro call

Why Entourage

15+

Years of industry experience in regulated markets

500+

Projects successfully completed

100%

Focus on life sciences

4

Offices: Munich, Basel, Milan, Boston

Expertise

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.

  1. 01Pre-Clinical
  2. 02Clinical
  3. 03Regulatory & Approval
  4. 04Launch
  5. 05Post-Launch
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.
All expertise areas →

How we work

Consulting in the format that fits your task.

All consulting formats →

Clarity before action.

Strategy Consulting

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

Learn more →

Your project. Our responsibility.

Project Consulting

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

Learn more →

Think and do.

Hybrid Consulting

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

Learn more →

Not sure which format fits?

The QuickCheck assesses your processes across 6 key areas and shows where the biggest levers are: 3 minutes, no registration.

Start QuickCheck →All readiness checks

Insights

Latest insights.

All insights →
Whitepaper

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.

Learn more →
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

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.

EU GMP Annex 1

Case Studies

Selected projects

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

Learn more →

Lean Six Sigma in Sterile Filling and Packaging

Implementing Lean Six Sigma in the sterile filling and packaging operations of a pharmaceutical company, focused on cost reduction and a global lean program.

Learn more →

Regulatory Strategy for 510(k) Clearance and Successful US Market Entry

An international MedTech manufacturer was preparing to enter the US market on a fixed timeline and without experience of FDA requirements. Entourage developed the regulatory strategy for the 510(k) clearance.

Learn more →

Improving Overall Supply Chain Effectiveness at a Medical Device Manufacturer

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

Learn more →

Regulatory updates

Stay on top of regulatory change.

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

Regulatory Update Hub

12 short expert videos 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.

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

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