Our Expertise
We support pharmaceutical and life sciences companies in strengthening compliance, improving operations, and moving projects forward.
SME in Aseptic Processing
Focused support in sterile manufacturing and contamination control.
We provide hands-on support in aseptic processing, aligned with EU GMP Annex 1 and current regulatory expectations.
- Aseptic process design and improvement
- Contamination Control Strategy (CCS)
- Environmental monitoring programs
- Media fill definition and support
- Investigation of contamination events and CAPA
- Preparation for inspections in sterile environments
- Overall process performance optimization.
EU GMP & Quality Systems
Keeping compliance practical and inspection-ready.
We support companies in building and maintaining quality systems that are workable and aligned with EU GMP.
- Support for GMP certification and inspections
- QMS design and improvement
- CAPA definition and follow-up
- GMP audits and supplier qualification
- Remote and onsite quality support
- GMP and technical training adapted to your needs
Manufacturing, Technology & Operations
Supporting consistent and efficient operations.
We work with manufacturing and technical teams to improve process reliability and ensure GMP compliance.
- Technology transfer (products, processes, analytical methods)
- Process improvement and deviation handling
- Integration of lean approaches in GMP environments
- Facility design and refurbishment
- Qualification and validation of equipment and utilities
Business & Program Delivery
Helping move projects forward.
We support companies in managing and delivering projects in a structured and realistic way.
- Business development and licensing support
- Strategic partnerships and due diligence
- Portfolio assessment
- Project management for facility upgrades, validation, tech transfer, and product launch
Regulatory & Market
Supporting regulatory pathways and product positioning.
We provide support across regulatory and market aspects to help products move forward.
- Regulatory strategy and authority interactions
- CTD/eCTD preparation and lifecycle management
- Variations and regulatory maintenance
- Market access considerations
- Intellectual property support
Tailored Solutions
No two situations are the same.
We adapt our support to each client’s context — products, facilities, teams, and regulatory environment.
The focus is always on practical solutions that can be implemented and maintained.