We cover all phases of drug development, validation and transfer, from early phase up to late phase development, marketed product support and line extensions. We can support you with practical technical issues, Quality by Design and also with the documentation for regulatory approval such as IMPD/IND and MAA/NDA. There is a long experience with quality systems such as GLP and GMP, Equipment Validation (Processing & Packing), Utility/Facility Qualification, Analytical Method Validation, Computer system validation, Validation Master Plan (VMP) Generation, Computer System Validation (CSV), Validation Risk Assessment, Cleaning Validation (Cross-Contamination Risk Assessment), Process Validation, Utilities Validation (HVAC, Purified Water, Compressed Air), New Facility Qualification
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