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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

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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

-30% contamination risk

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.

Pharma

Audit Software Integration for Improved Production Quality under GMP

Compliance with GMP standards

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.

Insights

Current insights.

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Insight

ISO 14971 risk management file: the review points in MDR Annex I and VII

The term risk management file does not appear anywhere in the MDR. What the regulation requires is a chain of six steps in Annex I Section 3, and Annex VII expressly has the notified body review the interfaces of that chain with the pre-clinical and clinical evaluation.

Regulation (EU) 2017/745 (MDR), Art. 10(2), Art. 61(10), Art. 83(3), Art. 86

Insight

Regulatory due diligence: the deadlines and registers against which a data room is measured (MDR Art. 120, IVDR Art. 110, EUDAMED, Art. 16 and 10a)

A data room shows what the target company produces. Whether that is enough is decided by the legal text: MDR Art. 120 ties continued sales under an MDD certificate to May 26, 2024 and September 26, 2024, IVDR Art. 110 sets staggered dates up to 2027, EUDAMED has been mandatory in four modules since May 28, 2026, and Art. 16 MDR turns a buyer who sells the device under its own name after closing into the manufacturer with all obligations. There are also three public registers: EudraGMDP, the EUDAMED module "Notified Bodies & Certificates" and the FDA Warning Letter database. What a regulatory due diligence has to establish per device, with references.

Regulation (EU) 2017/745 (MDR), Art. 10a, 16, 85, 86 and 120(2), (3) to (3f), (4) and (13), Art. 123(3), points (d) and (e) (consolidated version 02017R0745-20260719; Art. 10a, 120(13) and 123(3), points (d) to (ec), as amended by Regulation (EU) 2024/1860; last amended by Delegated Regulations (EU) 2026/1359 and 2026/1451)

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