services
GMP consulting, airflow studies, contract field technicians, automation, upgrades and maintenance, delivered by engineers and former sterile operators.
advice from people who ran these operations
Most technical service firms in this sector are staffed by engineers who learned pharmaceutical manufacturing from documentation. Our team is largely made up of people who learned it in production: former sterile operators, line leads and production managers who worked in gown daily, operated the equipment, authored deviations and supported regulatory inspections.
This affects the quality of the advice. We can tell the difference between a procedure that satisfies a standard and one an operator can realistically follow in gown across a full shift, and between a study that technically complies and one that withstands detailed regulatory scrutiny.
Discuss a scope →- Project. A defined scope with a deliverable: a study, an upgrade, a validation package or a design review.
- Retained advisory. Ongoing access to our engineers and QA specialists as questions arise across a program.
- Contract staffing. Our field technicians deployed to your team or your customers’ sites on flexible terms.
- Support agreement. Planned maintenance, spares and on-call cover for equipment we or others supplied.
six services, one accountable team
gmp consulting
Process, equipment, facility and utility design, QA systems and manufacturing operations.
Consulting scope →airflow studies
Cleanroom smoke studies run by experienced leads on our own software. Specialized in aseptic and sterile.
How we run them →oem field technicians
Contract service technicians for OEMs who need experienced hands without permanent headcount.
Staffing terms →automation
Controls, HMI, recipe handling and data systems, from new work to obsolete-platform migration.
Automation work →upgrades & repairs
Bring installed equipment up to current expectations, or back into production.
Upgrade scopes →maintenance
Planned and routine maintenance, on-call support, and help with complex repairs and service.
Maintenance plans →let’s talk about your pharmaceutical production.
Tell us what you are working on, whether it is refurbishing equipment, planning a new build or reviewing an existing process.