Area of expertise
Supply Chain & Technical Operations
Manufacturing and supply chain have to run GxP-compliant and economical at the same time. We support tech transfer and scale-up, GDP-compliant distribution and supplier qualification, shortage management as well as lean and digitalization programs, from the shop floor to validated IT, without losing regulatory control.
- Biotech
- IVD
- MedTech
- Pharma
All topics
27 topics in Supply Chain & Technical Operations
Automated Visual Inspection →
AVI consulting for visual final inspection: system selection and defect library, method validation with a probability-of-detection study and reference standard per EU GMP Guide Annex 1, computer system validation per GAMP 5, and ongoing performance monitoring of false-reject and detection rates.
Biotech Scale-up →
Scale-up consulting for biotech and biopharmaceutical companies: scientific support of the scale change in upstream and downstream, derivation of the critical process parameters under ICH Q8 and ICH Q11, comparability strategy under ICH Q5E, and process validation with PPQ under ICH Q7 and Annex 15 of the EU GMP Guide. The focus is on the scaling questions that distinguish biological processes from chemical synthesis.
Business, Data & IT →
Business, data and IT consulting for GxP-regulated life sciences companies: technology strategy and system selection, computerised system validation under GAMP 5, data integrity to ALCOA+, audit trail and e-signature design against 21 CFR Part 11 and the EU GMP Guide Annex 11, plus the integration of AI applications under the AI Act (EU) 2024/1689.
CAPEX Planning & Qualification →
CAPEX consulting for regulated production facilities: needs assessment and business case, User Requirement Specification with integrated GMP requirements, technical tendering and supplier selection, project controlling as well as FAT, SAT and qualification through to GMP-compliant commissioning, for pharma, biotech, MedTech and IVD.
Compliant Procurement Excellence →
Consulting for GMP-compliant procurement in life sciences: design of auditable procurement processes and SOPs, quality agreements with critical suppliers, risk-based supplier categorization and a procurement KPI system, aligned with supplier qualification, change control and the supplier audit program.
Digital Governance →
Digital governance for regulated life sciences IT: a complete system inventory with GAMP 5-based criticality assessment, defined system ownership across IT, QA and the business, IT policies for change control, access control and incident management in line with EU GMP Annex 11, plus integrated IT risk management and software lifecycle management - as a robust foundation for CSV and data integrity across all sectors.
Digitalization in Life Sciences →
Digitalization consulting for regulated Pharma, Biotech, MedTech and IVD environments: a GMP-compliant roadmap, paperless manufacturing with electronic batch records, risk-based system selection and the validated introduction of LIMS, eQMS, MES and ERP in line with GAMP 5 and EU GMP Guide Annex 11.
Energy & Resource Management →
Energy and resource management for regulated life sciences production: energy audit, consumption analysis across HVAC, compressed air and refrigeration systems, process optimization and implementation of an energy management system to ISO 50001, with robust data for ESG and CSRD reporting.
ERP Integration →
ERP integration for regulated life-sciences companies: GMP process design for batch management, goods receipt and batch release, interfaces to LIMS, MES and eQMS, risk-based validation in line with GAMP 5, plus GMP-compliant data migration and go-live management for SAP, Oracle and comparable systems.
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- 100% life sciences
- 500+ projects completed
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Other areas
Product Development & Regulatory Strategy
From classification and regulatory strategy through to development and study planning.
Market Access, RWE & Reimbursement
Market access, health economics, real-world evidence and pricing and reimbursement strategy.
Regulatory Affairs
Approval and conformity under MDR, IVDR and pharmaceutical law, from the technical documentation to the notified body.
Quality Management & Compliance
QM systems, audits, computer system validation and data integrity under ISO 13485, GMP and 21 CFR Part 11.
Your project
A concrete project in this area?
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info@theentourage.it
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- 4 offices: DE · CH · IT · US
- 100% life sciences