Key points at a glance
- Challenge: Buildings, process facilities, and qualification are often planned independently of one another in pharmaceutical projects. The consequences: Planning conflicts, skyrocketing costs, and delays in the start of production, as well as delayed manufacturing authorization and audit findings.
- Solution: io, your EPCMV partner (engineering, procurement, construction management, validation), delivers holistic life science engineering – all disciplines under one roof.
- Result: Accelerated time-to-market (“fast track”) and time-to-patient (supply reliability), planning and cost certainty, and a seamless transition from planning to GMP operations.
- Benefit: You have a single central point of contact for all project matters. We translate your process requirements into a comprehensive audit-ready system.
What is holistic life science engineering?
Complex pharmaceutical projects rarely fail due to individual machines or processes – they fail at the interfaces. When buildings, process technology, IT/automation, qualification, commissioning, and go-live are planned independently of one another, there will always be risks of delays, skyrocketing costs, and ultimately audit risks.
Our solution to the challenge is holistic engineering. We put an end to silo thinking. As your EPCMV partner, we view your project as an integrated, holistic system right from the outset. Your process and your specific product determine the building – not the other way around. We think in terms of processes, take a risk-based approach, and develop fast and sustainable solutions from the inside out.
- No interface gaps: Architecture, MEP, process engineering, and qualification (CQV) merge into a seamless, one-stop solution.
- Product-specific excellence: We know the exact regulatory requirements of your segment, whether it is drug substances – such as ATMPs, AGCs, or vaccines – or drug products – such as sterile filling, OSDs, or even cannabis.
- Built-in audit assurance: GMP compliance, risk analyses, and EHS are not dealt with as an afterthought but are at the foundation of every single planning phase.
Production of a biotechnological active ingredient.
Integrative planning by our inter-disciplinary teams ensures interface-optimized planning. We offer production-efficient, customized pharmaceutical planning to meet your specific production requirements.
Our many years of experience in pharmaceutical and biotech planning, particularly in facility planning for active drug substances (DS) and pharmaceuticals (DP), auxiliary substances, parenterals, solids, liquids and sterile filling, as well as in layout and laboratory planning, mean you will not find a more qualified partne
We have comprehensive GMP expertise and implement regulatory requirements (FDA, EMA), standards (DIN, ISO), and international quality standards (PIC/S, ISPE, ICH). We also carry out GMP compliance tests.
We offer technological solutions and innovations, including solutions for highly active ingredient applications, containment solutions and single-use technologies.
Our extensive range of expertise covers clean rooms and clean media supply, and we use the latest innovative tools for 3D planning, dimensioning and simulation.
Our services include end-to-end planning and integration of IT, automation, MES and SAP. We accompany you from the initial strategic ideas to the finalisation of your Computer System Validation (CSV).
Our comprehensive solutions in terms of sustainability and security include HVAC/MEP planning and HSE (health, safety and environment).
Detailed range of services
A holistic approach only works if you have a thorough understanding of every detail. We bring together specialized expertise from all critical disciplines of the life sciences industry, freeing you up to focus on your core business.
Discover our areas of expertise, which we seamlessly integrate into your project:
Segments & product range ×
- Vaccines
- ATMP / cell & gene therapy
- Drug substance (biotech APIs, including MABs, mRNA, peptides, ADCs, and proteins)
- Drug substance (chemical APIs, including herbal extracts and cannabis)
- Drug product (sterile & aseptic manufacturing, OSD, semi-solid)
- Medical devices
- Nutrition & food supplements
- Cosmetics / FMCG
- Laboratories (QA/QC)
Value chain & project management ×
- Consulting & planning
- Project management & project control
- Construction management
- Installation and start-up services
- Qualification & validation
- GMP compliance
Process expertise ×
- Biotechnological manufacturing processes (fermentation / cell culture)
- Sterile manufacturing & solid handling
- Continuous manufacturing (CM)
- Plant extraction
- Pure media (DL, PW, WFI, RD, gases)
- Process automation / IT / digitalization
- Containment up to OEB level 5/6
- Weighing, batching, filling, lyophilization
- Inspection & packaging
- Intralogistics & supply chain
- Clean room technology & 3D facility planning
Cross-functional analyses & cross-cutting topics ×
- Site & network analyses
- Economic feasibility studies
- Risk analyses (GMP compliance and process)
- Environmental, health and safety (EHS)
- BImSchG (Germany’s Federal Emissions Control Act)
Efficient GMP planning and implementation
From the initial consultation to audit-ready certification—io supports your project as an integrated partner through all four phases.
GMP-Consulting / SME
Our expertise begins with a thorough analysis and solution-oriented consulting direct from our subject matter experts (SMEs). We cover active pharmaceutical ingredient (API) manufacturing (DS), pharmaceutical finished product (DP) manufacturing, clean media, and containment, and provide support in general technology selection, optimization of existing process plants, as well as clean room and zoning strategies. This is complemented by GMP audits and operational excellence consulting.
Planning
From feasibility studies through concept design to detailed engineering: We translate regulatory requirements (FDA, EMA, EU-GMP Annex 1) into robust layouts, HVAC design, and process plant specifications. All disciplines – construction, MEP, process, and IT – are fully coordinated within a shared 3D model.
Implementation
As an EPCMV partner, we are responsible for project management, engineering, procurement, construction management, and validation under a single contract and for the entire project. We manage all contractors, monitor quality and schedules, and ensure a seamless handover to operations – without any interface risks for the client.
Commissioning / qualification / validation (CQV)
Seamless demonstration of GMP compliance: We provide the complete qualification documentation (DQ/IQ/OQ/PQ) to ensure audit readiness with the FDA, EMA, and local authorities. Commissioning, qualification & validation (CQV) from a single source – for a smooth go-live.
Your benefits with io life sciences
GMP experts
Process expertise
Our engineers are not merely building designers. We understand the machinery, the parameters, and the strict GMP regulations in detail.
All under one roof
100% EPCMV delivery
No loss of efficiency. We take responsibility for engineering, procurement, construction management, and validation as an integral partner.
Fast track
Implementation
We bring your product to market faster by seamlessly integrating detailed engineering, construction, and qualification.
100%
Audit assurance
We support you right from the preparation stage to ensure a successful audit by the FDA and EMA through our “Quality by Design” principle and integrated CQV strategy.
FAQ
What is the difference between traditional general planning and an EPCMV partner? ×
A traditional general planner coordinates architecture and construction (MEP). An EPCMV partner (engineering, procurement, construction management, validation) goes much deeper: They are also responsible for the complete process plant design (process), procure the machinery, and handle the final GMP qualification. This drastically reduces interfaces.
Do you also support brownfield projects during ongoing operations? ×
Yes, expansions or retrofits while production is ongoing are our daily business. Among other things, we develop detailed hygiene and airlock protocols, as well as material and personnel flow strategies, to meet GMP compliance requirements.
How do you ensure compliance with the new EU GMP Annex 1? ×
The contamination control strategy (CCS) is at the heart of our clean room and process planning. We design layouts and HVAC protocols that minimize personnel intervention and guarantee the highest aseptic standards.
Do you also offer pure CQV services? ×
Yes. Even if we did not design your systems ourselves, we handle qualification and validation (DQ/IQ/OQ/PQ) as an independent partner to bring systems up to an audit-ready state.
Do you provide support in selecting process equipment? ×
Absolutely. As an independent engineering firm, we develop URS (user requirement specifications), manage the bidding process, objectively evaluate suppliers, and oversee FAT and SAT.
Schedule a consultation with an expert
We’ll work together in a 30-minute session to identify which area of action offers the greatest leverage for your current situation – and whether a structured pilot approach makes sense for you.
