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Entourage

Industries

Four industries. One consultancy.

Most consultancies cover a niche. Entourage works across the full spectrum, with genuine depth in each of the four industries.

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Four sectors, one consultancy

Each sector, its own requirements.

Pharma, Biotech, MedTech, and IVD share a regulatory framework, but requirements, approval pathways, and market logic differ significantly. A medicinal product follows different rules than a class III medical device, and an IVD follows different rules again from a Biotech product in clinical development. Entourage has genuine depth across all four sectors, with consultants who have worked exclusively in these areas for years.

Regulatory coverage

  • Pharma: AMNOG, GMP, pharmacovigilance, approval under AMG
  • Biotech: clinical development, CMC, Orphan Drug, ATMPs
  • MedTech: MDR, clinical evaluation, notified body, post-market
  • IVD: IVDR, performance evaluation, CE marking

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Our sector expertise

Explore your sector

Pharma

Hands-on support across the entire lifecycle, from drug substance research to GDP-compliant distribution. On the ground, from the shop floor to the authority dossier.

  • EU GMP Annex 1: contamination control strategies and sterile manufacturing
  • Inspection readiness and mock audits for FDA and EMA inspections
  • CSV and data integrity per GAMP 5, ALCOA+ and 21 CFR Part 11
  • Tech transfer and scale-up with process validation (PPQ)
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Biotech

From biomedical research to industrial GMP manufacturing: scale-up from lab scale to commercial production of biologics, with complete process characterization and CMC documentation.

  • Bioprocess development and scale-up: CPPs/CQAs, DoE, PPQ
  • ATMP and cell/gene therapy: GMP manufacturing and EMA/FDA approval
  • CMC for biologics and biosimilars per ICH Q5, Q6B, Q8-Q12
  • GDP-compliant cold-chain logistics for temperature-sensitive products
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MedTech

From product development to post-market surveillance: the EU MDR translated pragmatically into day-to-day development, for a time-critical, audit-ready market access.

  • EU MDR (2017/745), CE marking and legacy device transition
  • Design controls and usability per IEC 62304 and IEC 62366
  • Clinical evaluation (CER) per MEDDEV 2.7/1 Rev. 4 and PMCF
  • Risk management per ISO 14971, biocompatibility per ISO 10993
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IVD

Through the IVDR paradigm shift in clinical evidence and performance evaluation: from assay development to the post-market phase, including portfolios with 200+ products.

  • IVDR (2017/746): reclassification per Annex VIII and transition
  • Performance Evaluation Reports (PER), especially class C and D
  • Companion diagnostics: alignment between IVD, pharma and authorities
  • EUDAMED registration, UDI, post-market surveillance and PSUR
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Case Studies

Projects we have completed.

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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

Insights

Current insights.

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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)

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.

Regulation (EU) 2024/1689 (EU AI Act)

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