Right the first time
BOUTIQUE GMP CONSULTANCY
Pharma is complex enough.
Your consultancy shouldn't be.
A boutique GMP consultancy that help pharmaceutical companies turn complex challenges into practical solutions.
Experienced hands, straightforward collaboration and measurable impact
OUR SERVICES
Specialist support accross the pharma lifecycle.
Qualification & Validation
- Validation strategy & planning
- FAT / SAT and operational readiness
- IQ/OQ/PQ execution
- Equipment, facility & storage qualification
- Risk assessments & Change control
- Inspection-ready documentation
Aseptic Manufacturing and Annex 1
- Aseptic filling and isolator qualification
- Environmental monitoring strategy
- Smoke studies and first-air assessments
- Single-use systems
- Annex 1 gap assessments and compliance support
Technical Project Management
- Project and programme leadership
- Project planning and execution
- Cross-functional coordination
- Stakeholder and supplier management
- Project recovery and close-out
Quality & Regulatory
- GMP/GxP quality systems and documentation
- Deviations, CAPA and change control
- Medical-device quality and regulatory support
- AI governance and draft EU GMP Annex 22 readiness
- Data integrity and computerised systems compliance
Have a project that needs to move?
You don't need a perfect brief. Tell us what you're working on, what you need and when - and we will take it from there.
