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Regulatory & Compliance

GMP Consulting.

We help pharmaceutical, biotech, and medtech companies establish, document, and ensure regulatory compliance of their GMP-compliant production processes—from gap analysis through to inspection.

Pharmaceutical technicians inspect a sterile filling line under GMP conditions

What is GMP consulting? GMP consulting supports pharmaceutical, biotech, and medtech companies in implementing Good Manufacturing Practice in accordance with the EU GMP Guidelines and 21 CFR Part 210/211. It includes gap analyses, QMS implementation, SOP development, staff training, and inspection preparation—with the goal of securing regulatory approvals and obtaining manufacturing licenses.

What GMP challenges do manufacturers face in practice?

Good Manufacturing Practice (GMP) in accordance with the EU GMP Guidelines and 21 CFR Parts 210 and 211 is an absolute prerequisite, yet its implementation in day-to-day operations often stalls:

  • Outdated SOPs and documentation no longer comply with the current version of the EU GMP guidelines or the ICH guidelines.
  • Strict GMP inspections by the EMA, FDA, or national authorities often result in costly critical findings or non-conformities.
  • Staff turnover strips teams of critical GMP knowledge and jeopardizes ongoing compliance.
  • Scale-up processes and technology transfers are implemented without adequate GMP support, leading to massive production losses.
Are you sure your current quality management system could withstand an unannounced FDA or EMA inspection?
Quality control inspector checks batch record documentation with a ruler

Our GMP consulting services.

We can assist you in establishing a new GMP system, as well as with targeted optimization and preparation for regulatory inspections.

GMP Gap Analysis & Assessment
A systematic assessment of your current GMP status against the EU GMP Guidelines (Annexes 1–20) and FDA requirements. You will receive a prioritized action plan with a timeline and resource allocation.
QMS Implementation & GMP Documentation
Development of a comprehensive and practical GMP quality management system: SOPs, batch records, change control, and CAPA. We ensure a clear, audit-ready document structure.
GMP Training & Qualification
Practical training for production staff, QA teams, and managers on GMP fundamentals, hygiene, documentation requirements, and deviation management—including in-house training at your facility.
Inspection Preparation (Mock Audits)
We simulate FDA and EMA audits under real-world conditions. We prepare the inspection team, develop a defense strategy, and assist you in addressing any questions that arise.

What is the process for a GMP project with ENTOURAGE?

A structured 5-phase implementation process—from the initial assessment to confirmed readiness for inspection.

01

Kickoff

Assessment: product portfolio, manufacturing authorization, past inspection history, and priorities.

02

Gap Analysis

Systematic review against EU GMP guidelines, annexes, and FDA 21 CFR. Prioritized action plan.

03

Implementation

Create SOPs, batch records, change control procedures, CAPA processes, and validation documentation.

04

Mock Audit

Simulation of an FDA/EMA inspection using an actual question-and-answer protocol. Identify any remaining weaknesses.

05

Inspection & Follow-up

Assistance during regulatory inspections. CAPA tracking and ongoing GMP follow-up.

GMP
“GMP compliance isn’t a project with an end date. If you don’t start until three months before the inspection, you’ve already lost. The companies that succeed have integrated GMP into their daily operations.”
GMP Consulting Team, ENTOURAGE

Frequently Asked Questions About GMP Consulting.

Which companies are subject to GMP?
GMP is mandatory for manufacturers of pharmaceuticals, active pharmaceutical ingredients (APIs), sterile products, blood products, and certain medical devices. CDMOs, contract manufacturers, and importers are also subject to these EU requirements.
What is the EU GMP guideline?
It is the central regulatory framework for Europe. It is divided into Part I (human medicinal products), Part II (APIs), and Annexes 1–20, which cover specific topics such as sterile manufacturing (Annex 1) and computerized systems (Annex 11).
What exactly is the difference between GMP and GxP?
GMP (Good Manufacturing Practice) refers to manufacturing practices and is a subset of GxP. GxP is the umbrella term for all "Good Practice" regulations, such as GLP (laboratory), GCP (clinical trials), or GDP (distribution).
What happens if a critical finding is identified during a government audit?
A critical finding can lead to a temporary production shutdown, a product recall, or the suspension of the manufacturing license. The only solution is an immediate, structured CAPA plan with clearly scheduled actions.
How much does GMP consulting cost?
The effort required depends on the scope and the initial situation. A gap analysis typically takes 3–5 consultant days. Full implementation projects range from 20 to 60 consultant days, depending on the size of the site. A free initial consultation will help determine your specific needs.
Do you also prepare for FDA inspections?
Yes. We prepare companies for inspections by the EMA, FDA, PIC/S authorities, and national regulatory agencies (e.g., Regional Council, AGES, Swissmedic). This includes mock audits, back-office strategy, and coaching for the inspection team.

Additional expertise in compliance and quality.

Expertise

Annex 1 Consulting

Specific GMP compliance for sterile pharmaceuticals and cleanrooms.

 Expertise

Inspection Readiness

Preparation for inspections by the FDA, EMA, and local authorities.

 Expertise

CAPA Management

Systematic corrective actions for GMP deviations.

Obtain your manufacturing license.

Regulatory inspections do not tolerate any gaps in the GMP system. We bring your SOPs, batch records, and validations up to audit standards in a timely manner.

Submit a project inquiry.

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