01
Regulatory Affairs
Assessment, submissions, registration and ongoing compliance.
- Requirements assessment
- Product registration and submissions
- Dossier preparation and review
- Licensing and permit support
Services
Six service lines
Engage one, or combine them into a compliance programme.
02
Quality Management Systems
SOPs, CAPA, deviations, change control and risk management.
- Quality manual and policy
- SOPs and work instructions
- CAPA and deviation systems
- Change and document control
03
GMP & GxP Compliance
GMP, GDP and GSP assessments. Inspection readiness.
- GMP assessment and gap analysis
- GDP and GSP assessments
- Validation and qualification support
- Supplier qualification
04
Quality Control & Laboratory Systems
QC systems, analytical quality and laboratory compliance.
- QC system design
- Analytical quality and method control
- Data integrity review
- Instrument qualification support
05
Training & Capacity Building
GMP, QMS, regulatory affairs, QA/QC and risk management.
- GMP and GxP awareness training
- QMS and SOP training
- Regulatory affairs fundamentals
- QA/QC technical training
06
Operational Excellence
Lean and Six Sigma. Root-cause analysis. KPIs.
- Process performance assessment
- Root-cause analysis (DMAIC)
- Quality KPI development
- Continuous improvement programmes
Not sure where to start?
Most clients begin with an assessment.
It establishes where you stand before anyone commits to scope.