Industries.
Pharma Consulting.
Advice on GMP, GxP & approval - regulatory certainty through all phases.
Authorities such as the EMA, FDA and Swissmedic are increasingly demanding detailed evidence and conducting stricter audits. At the same time, time-to-market deadlines are decreasing, meaning that technology transfer, supplier qualification, digital validation and regulatory communication must be implemented efficiently and in compliance with GxP. Systems such as ERP, CSV and Data Integrity solutions, as well as GMP, GLP and GCP, require seamless integration and ongoing optimization to ensure compliance, product quality and audit readiness.
With comprehensive industry expertise, we support you throughout the entire product life cycle - from development and clinical trials to approval and production. Our consultants combine regulatory, operational and technological expertise, focus on best practices, optimize your quality management according to ISO 9001 and strengthen your structures sustainably through CAPA management, deviation control and targeted mock inspections.
Our consulting fields - regulatory, operational and technologically networked.
Regulatory & Compliance.
- Regulatory Affairs - Strategic advice and coordination of approval processes
- International market access - strategies for worldwide submissions and approvals
- Health Authority Interaction - support in communication with EMA, FDA, BfArM etc.
- Risk Management - Application of ICH Q9 for risk management in the approval process
- Change management compliance - compliant control of changes in the lifecycle
- 21 CFR Part 11 and data integrity - implementation of US regulatory requirements for electronic data
- Data Integrity Assurance - ensuring data integrity in accordance with international standards
- GxP compliance audits - checking and ensuring regulatory standards
- Good Laboratory Practice (GLP) - Establishment and auditing of GLP-compliant study processes
- Inspection readiness - preparation for regulatory inspections
- Mock audits - Simulated inspections to prepare for audits by authorities
Clinical & Medical Affairs.
- Clinical Affairs - Strategic study planning, endpoint definition and study architecture
- Clinical Project Management - coordination and monitoring of complex study projects
- CRO support - assistance with the selection and management of service providers
- Medical writing - preparation of protocols, IBs, CSRs etc.
- GCP compliance - ensuring adherence to clinical standards
- Clinical monitoring - quality control in study centers and data flow
- Pharmacovigilance - Establishment and maintenance of a GVP-compliant PV system
- QPPV - Responsible Person for Pharmacovigilance according to EU directives
- Signal Detection - data analysis for risk detection and early warning
- Post Market Surveillance - Long-term monitoring after market approval
Quality Management & Operational Excellence.
- Quality management - development and maintenance of a comprehensive QMS according to GMP/GDP
- Annex 1 - Implementation of requirements for sterile drug manufacturing
- Process validation - validation of critical production processes
- Deviation management - control and analysis of production deviations
- CAPA management - derivation and follow-up of corrective measures
- Complaint Management - Complaint management and evaluation
- Automated visual inspection - support for the selection, validation and optimization of automated inspection systems
- Lean Lab - Efficiency optimization in the laboratory environment
- Continuous Improvement Programs - Sustainable optimization initiatives in operations
- Cleanroom qualification and management -Environmental control and validation
Research & Development and Engineering.
- CMC - Regulatory compliant preparation of chemical-pharmaceutical dossiers
- Design Controls - Structured product development with mandatory documentation
- Feasibility studies - analysis of the feasibility and prospects of success of developments
- Biocompatibility Studies - Compatibility assessment of materials
- Verification & Validation - checking product requirements and process performance
Manufacturing and Supply Chain Management.
- Good Manufacturing Practice - establishing and auditing regulatory compliant manufacturing processes
- Production Transfer & Scale-Up - Transfer and scaling of pharmaceutical manufacturing processes
- Supplier Development & Qualification - Selection, development and qualification of external partners
- Good Distribution Practice (GDP) - Ensuring regulatory requirements in distribution
- Supply chain governance - structured supply chain management and allocation of responsibilities
- Lean manufacturing - increasing efficiency through lean production
- Sustainable Manufacturing - Sustainable production concepts and resource conservation
- Logistics Optimization - Optimization of warehouse and transport processes
Business Data Solutions & IT Services.
- Technology Excellence - Identification and introduction of innovative digital technologies
- Digitalization - Digital transformation of regulatory and operational processes
- Digital governance - management and control of digital systems in a regulated environment
- IT process management - structuring and improving IT-supported processes
- ERP integration - integration of ERP systems into regulated processes
- Computer System Validation - Validation of computerized systems according to GAMP 5
Do you want to set up GMP processes, achieve audit security or prepare for international approval?
Successful consulting projects in pharma consulting.
Challenge.
A growing CDMO was about to have its first EMA inspection, but had only a rudimentary quality system without clear responsibilities and SOP structures.Measures.
Strategic overall QMS planning by senior consultant. Operational implementation on site: SOP creation, training, mock audits. Introduction of a CAPA and audit tracking tool.Results.
- EMA inspection passed without deviation
- Reduction of SOP review times by 35
- Structured CAPA tracking for the first time
Success.
The site became an internal benchmark for other plants.Get to know our experts.
Get in touch with our experts from Pharma.
Dr. Nils Sunder-Plassmann
Andreas Weirich
Do you want to secure your pharmaceutical
zeutical processes from a regulatory perspective and improve them operationally?
FAQ - Frequently asked questions about pharmaceutical consulting from Entourage.
We specialize in the life sciences sector - with a focus on pharmaceuticals, biotechnology, medical technology and IVD. Our consultants have many years of experience in the industry: they have previously worked as QP, Head of QA, RA Manager or Clinical Lead.
What makes us special:
- In-depth regulatory expertise with a focus on GxP, marketing authorization, pharmacovigilance
- Operational implementation strength directly from everyday pharmaceutical practice
- Experience with EMA, FDA, Swissmedic requirements and country-specific regulations
- Process-oriented consulting that integrates into your structures - strategically and operationally
Our services can be flexibly adapted to your project requirements:
All models are modular, scalable and geared towards life science requirements.
We advise:
- Pharma start-ups with a focus on GMP/GCP implementation
- Medium-sized CDMOs with growing audit requirements
- International companies with complex administrative landscapes
- Manufacturers of active ingredients, finished medicinal products or combination products
Yes - we offer EMA, FDA, Swissmedic and BfArM readiness programs, inclusive:
- Mock audits
- CAPA strategy development
- Audit trail/data integrity checks
- Response support for 483-notices
- Support during the on-site inspection
- Kick-off & target definition
- Gap analysis or process mapping
- Joint project planning with clear role allocation
- Implementation & review cycles
- Handover, reporting & lessons learned
Project types range from 2-week sprints to GMP, CSV or QMS implementations lasting several months.
We work transparently and precisely:
- Fixed daily rates or project-related offers
- No hidden additional costs
- Option of interim solutions for longer resource requirements
Yes - online or on site. Examples:
- GxP basic training courses
- 21 CFR Part 11 & Data Integrity
- Audit behavior & CAPA culture
- QMS training for new locations
Yes - in the event of inspection preparation, acute quality problems or breakdowns, we can provide support within 48 hours - nationally and internationally.
