Industries.
Biotechnology Consulting.
Advice on GMP, GxP & approval - regulatory certainty through innovation and growth.
Biotechnology companies operate in a highly dynamic environment between innovation, regulatory complexity and increasing time pressure - we help you to successfully master these challenges.
Approval processes for biologics, ATMPs and first-in-class therapies are demanding: authorities such as the EMA, FDA and Swissmedic require reliable CMC data, structured health authority interactions and comprehensive documentation across all development phases at an early stage. At the same time, GLP, GCP and GMP must interact seamlessly - often under tight time constraints and limited resources. In addition to stable tech transferand scale-up processes, robust quality systems and the GxP-compliant integration of ERP, LIMS and CSV systems are crucial for sustainable success.
With a deep understanding of the specifics of the biotech industry, operational implementation expertise and experience from numerous complex regulatory projects, we provide you with flexible support throughout your entire product development and approval process. We optimize your quality management systems, validate your digital infrastructures, stabilize your supply chains and strengthen your audit readiness - individually, purposefully and efficiently.
Our consulting fields - biotech-specific networking and regulatory protection.
We offer a comprehensive consulting portfolio for biotech companies - along the entire lifecycle and tailored to the specific challenges of biological products and innovative therapies.
Regulatory & Compliance.
Regulatory clarity and compliance security for biological innovations.
- Regulatory Affairs - approval strategies for biologics, ATMPs and new drug classes
- Approval of ATMPs & biologics - consulting for cell and gene therapy products
- Health Authority Interaction - Scientific Advice, Pre-Submission Meetings, Orphan Designation
- International market access - coordination of global submissions (EU, US, CH, APAC)
- Change management compliance - controlling regulatory changes in the lifecycle
- 21 CFR Part 11 and data integrity - validation of electronic systems (CSV, LIMS, ERP)
- Data Integrity Assurance - ensuring complete, consistent, valid data
- Risk management - ICH Q9-compliant risk analyses in R&D, quality and production
- GxP compliance audits - GMP-, GCP-, GLP- and GDP-compliant audits
- Mock audits - Realistic audit simulation to identify critical GxP gaps
- Inspection readiness - structured readiness program incl. SOP check, role clarification and training
- ISO audits - support with system audits and quality assurance
- Good Laboratory Practice (GLP) - Establishment and auditing of GLP-compliant study processes
- Technical writing - creation of regulatory documents such as IB, IMPD, SOPs, CTD
Clinical & Medical Affairs.
Efficient, safe and regulatory compliant clinical development for biologics.
- Clinical Affairs - Study planning, endpoint selection and feasibility for biotech products
- Clinical project management - management of early and late phase projects
- Medical writing - protocols, IBs, CSRs, IMPDs
- GCP compliance - setting up and safeguarding GCP-compliant systems
- Clinical monitoring - quality control in study centers
- Pharmacovigilance - Establishment and maintenance of a GVP-compliant PV system
- QPPV - Responsible Person for Pharmacovigilance according to EU directives
- Signal detection - early warning systems for detecting risk signals
- Post Market Surveillance -PMS strategies for biologics after approval
- CRO support - selection, management and auditing of contract researchers
Quality Management & Operational Excellence.
Structured quality management and robust processes - GMP-ready right from the start.
- Quality management - setting up a QMS in accordance with GMP, GLP and ISO 9001
- Annex 1 - Cleanroom and hygiene requirements for cell culture, fermentation, aseptic processes
- Process validation - qualification of production systems and critical manufacturing processes
- Deviation management - control and analysis of production deviations
- CAPA management - derivation and follow-up of corrective measures
- Automated visual inspection - support for the selection, validation and optimization of automated inspection systems
- Complaint management - analysis and processing of product complaints
- Lean Lab - Efficiency optimization in R&D and QC labs
- Continuous Improvement Programs - Sustainable optimization initiatives in operations
- Cleanroom qualification and management - Validation of controlled environments
- Lean Six Sigma - Data-based process optimization in production
- State of the art assessments - comparison of current processes with regulatory and technological benchmarks
Research & Development and Engineering.
Development of innovative biotech products - with regulatory support right from the start.
- CMC - Creation of complete modules 3 incl. production data, analytics and stability
- Design Controls - Development documentation for biologics with QbD principles
- Feasibility studies - feasibility analyses and early risk assessments
- Biocompatibility studies - testing of biological materials (e.g. carrier materials for ATMPs)
- Verification & Validation - Testing requirements and effectiveness
- Prototyping - development and validation of functional models
Manufacturing and Supply Chain Management.
GMP-compliant and scalable manufacturing and delivery processes - for growth and approval.
- Good Manufacturing Practice - Establishing regulatory compliant manufacturing processes for biologics and ATMPs
- Production Transfer & Scale-Up - Technology transfer from the laboratory to production
- Supplier Development & Qualification - Selection and qualification of biorelevant suppliers
- Good Distribution Practice (GDP) - temperature control, track & trace, logistics validation
- Supply chain governance - management and accountability structures for global supply chains
- Lean manufacturing - increasing efficiency in cell culture or fermentation processes
- Sustainable Manufacturing - Sustainable concepts for resource conservation and CO₂ reduction
- Logistics Optimization - Optimization of cold chains, transport and storage
- CapEx - Project support for investments in biotech infrastructure
- M&A & PMI - Quality assurance and compliance in the context of transactions
- Energy & Resources Management - Sustainability in biotech production and supply
- Compliant Procurement Excellence - Supplier selection and purchasing in a regulated environment
- Dealing with supply bottlenecks - strategies for safeguarding critical materials
Business Data Solutions & IT Services.
Digital systems and data quality under regulatory control.
- Digitalization - transformation strategies for R&D, quality and production
- Computer System Validation - Validation of LIMS, ERP, MES, CTMS
- Digital governance - controlling and monitoring digital workflows under GxP
- ERP integration - biotech-specific integration and process customization
- IT process management - structuring and improving IT-supported processes
- Data Integrity Assurance - Data quality and security in digital systems
- Technology Excellence - selection and introduction of innovative technologies
- Reporting & dashboards - visualization of regulatory key figures
- ERP & Software Implementation Support - Technical support for system implementations
- Audits & Quality Assurance for IT Systems - auditing IT systems for GxP compliance
Set up your biotech processes efficiently and audit-ready.
Successful consulting projects in biotechnology consulting.
This is how we bring biotech projects safely and efficiently to approval.
Audit readiness for a growing biotech company
CMC support for first-in-class biologics
Approval strategy for an ATMP therapy
Project type: Hybrid Consulting.
Challenge.
A biotech start-up was facing its first EMA inspection - with an incomplete QMS, missing SOPs and an uncertain audit process.Measures.
Establishment of a complete GMP-compliant quality system, creation and training of central SOPs, performance of a mock audit with subsequent CAPA implementation.Results.
- EMA inspection passed without critical deviation
- Internal SOP cycle times reduced by 40
Success.
The company received market approval and was able to quickly attract new investors.Get to know our experts.
Get in touch with our experts from Pharma.
Dr. Nils Sunder-Plassmann
Head of Pharma
Andreas Weirich
Head of Pharma Sales
Taking your biotech processes to the next level together.
FAQ - Frequently asked questions about biotech consulting from Entourage
We specialize in the life science industry - with a deep understanding of the special requirements of biotech products. Our consultants have many years of experience in the development, manufacture and approval of biologics, ATMPs and first-in-class products.
What makes us special:
- Regulatory expertise in CMC, GCP, GMP and GLP - especially for biotech
- Experience with approval strategies for ATMPs, biologics and orphan drugs
- Interdisciplinary consulting - from scientific advice to scale-up and inspection preparation
- Operational implementation directly in the company - e.g. when setting up QMS, preparing for audits or validating digital systems
Our services can be flexibly adapted to your project requirements: All models are modular, scalable and tailored to biotech-specific challenges - from start-ups to established companies.
We advise:
- Biotech start-ups in setting up regulatory structures (CMC, GCP, GMP)
- Companies with a focus on cell and gene therapies, biologics or platform technologies
- CDMOs with increasing audit complexity or technology transfer projects
- Organizations in clinical phases I-III with a need for project management, documentation and communication with authorities
Yes - we support you from the pre-IND phase through to MAA/BLA submission. Our services include
- EMA Scientific Advice, FDA Type B Meetings, Orphan Drug Designation
- Creation and review of Module 3 (CMC), IMPDs, IBs
- Strategies for centralized or decentralized procedures (EU)
- Mock audits and CAPA strategies prior to FDA or EMA inspections
- Support with 483 notices, warning letters and audit response
- Kick-off & target definition
- Gap analysis (e.g. GxP systems, CMC documentation)
- Project planning with clear allocation of tasks and roles
- Operational implementation incl. validations, documentation and training
- Review cycles & lessons learned
Project formats range from targeted 2-week sprints (e.g. SOPs, mock audits) to several months of support for scale-up, CSV or QMS development.
We work transparently and precisely:
Fixed daily rates or project-based offers
No hidden additional costs
Flexible interim solutions in the event of staff shortages (e.g. QP or QA replacement)
Support for public funding projects (e.g. Go-Bio, SME instruments)
Yes - online or on site. Popular formats:
- GxP basics especially for biotech (GMP, GLP, GCP, GDP)
- Audit behavior & CAPA culture in growing companies
- Data integrity & CSV for research, development and production
- QMS introduction for new locations or after merger/spin-off
Yes - we are ready for action within 48 hours, for example for
- Preparation for short-term inspections (EMA, FDA)
- Loss of internal resources in QA, RA or Clinical
- Crisis intervention for audit findings, documentation gaps or change controls
- Interim solutions for CMC, CSV, Clinical or PV
