VALIDATION & COMPLIANCE SERVICES
Validation proves that your processes consistently produce products that meet specifications. Regulators require it, and we handle the documentation and testing to show compliance with cGMP standards.
We validate pharmaceutical manufacturing processes, equipment, and systems.
How We Approach It
Risk Based Focus : We identify which process parameters actually matter for product quality, then focus validation efforts there instead of treating everything equally.
FDA Three-Stage Lifecycle : Design, qualification, and ongoing verification. We follow the established regulatory framework rather than inventing custom approaches.
ICH Q9 Risk Assessment : Every validation program starts by identifying what could actually go wrong and what needs the most attention.
Focused Documentation : We document what regulators need to see without creating unnecessary paperwork that doesn't add value.
What We Validate
Process Validation
- Manufacturing process consistency
- Process Performance Qualification
- Ongoing verification programs
Cleaning Validation
- Cleaning procedure development
- Residue limit calculations
- Swab and rinse sampling
Analytical Methods
- ICH Q2(R1) validation
- Accuracy and precision testing
- Method transfers between labs
Equipment Qualification
- Design to Performance Qualification
- Factory and Site Acceptance
- Calibration program support