GMP consultancy, shaped around your operation.
Choose the expertise you need or bring related workstreams together. W2 supports new facilities, existing GMP operations and inspection remediation.
New builds & cleanroom design
GMP input from concept and layout review through URS, design qualification and construction.
02GMP inspection remediation
Risk assessment, root-cause challenge, CAPA and a governed route to compliance recovery.
03Validation & qualification
Lifecycle strategy and evidence from DQ through IQ, OQ and PQ.
04Contamination Control Strategy
Connect facility, process, monitoring and operational controls around the actual risks.
05Quality systems & operational GMP
Strengthen documentation, investigations, change control and management oversight.
06Data integrity & computerised systems
Practical review of data governance, computerised systems and lifecycle controls.
07URS & Design Qualification
Translate intended use and risk into traceable requirements and design evidence.
08Inspection readiness
Independent gap assessment, mock inspection and preparation of evidence and people.
09Operational GMP support
Review the procedures, records, behaviours and governance used in routine operation.
Clear work. Clear responsibilities.
Each engagement starts with the process, product risk and project stage. We agree the outputs, boundaries and review arrangements. Client decisions, approvals and licence holder responsibilities remain within the client’s own Pharmaceutical Quality System.
You don’t have to work it out alone.
Tell us what you are planning or working through. We’ll help you make sense of the next step and agree where we can support your team.