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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)

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)

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