Post approval support
Maintaining Compliance and Performance After Approval
We help you maintain validated processes, strengthen control strategies, and adapt efficiently to post-approval changes, ensuring continued compliance and product quality throughout the commercial lifecycle.
- Overview
- How we support you
- Our core capabilities
- Our therapeutic modalities
- What this stage enables for your programme
- Why it's different working with us
- In our own words
Approval is not the finish line, it’s the start of continual oversight. Once your process is commercialised, every change, deviation, and improvement must be scientifically justified and regulatory aligned.
We support you in managing that complexity. We help you sustain process robustness, implement improvements safely, and document changes with the same rigour that earned approval in the first place.
From lifecycle management to change control and ongoing validation, we ensure your process, data, and documentation remain compliant, efficient, and future-ready.
Our Post Approval Support Capabilities
• Continued process verification and performance trending
• Root cause analysis and deviation investigations
• Lifecycle documentation and control strategy refinement
• CAPA implementation and monitoring
• Change impact assessments and comparability packages
• Global regulatory submission support (variations, supplements)
• Authority communication and inspection preparation
• Tech transfer support for secondary or new manufacturing sites
• Process efficiency reviews and re-optimisation
• Green chemistry and waste minimisation strategies
• Scale transition studies for new equipment or sites
• Energy, solvent, and yield performance benchmarking
• Method revalidation and lifecycle management
• Specification change control and analytical harmonisation
• Trending of critical quality attributes (CQAs)
• Stability monitoring and data integrity oversight
What This Stage Enables for Your Programme
We ensure your commercial process remains as robust and compliant as it was on the day of approval and becomes more efficient over time.
Our integrated support ensures your product maintains consistent quality, your documentation stays inspection-ready, and your process continues to deliver value throughout its lifecycle.
This allows you to sustain uninterrupted commercial supply with full regulatory assurance and to make sure you can implement improvements or changes without jeopardising compliance.
Why It’s Different Working With Us
