Manufacturing and Production Support
Well-planned transfer from development to plant, with fewer deviations and better yield.
ICH Q8, Q10, Q11; EU GMP Annex 15; FDA process validation guidance
How we can help
- Technology transfer packages and site-readiness assessments
- Scale-up strategy and equipment-fit assessment
- Process validation strategy and protocol design; cleaning validation approach
- Yield and cost improvement recommendations from batch record and deviation review
- Continuous process verification plan: what to monitor and how to act