Transfer and registration
We are experts in pharmaceutical industry standards,
and we will support your quality and registration activities hands-on
Support of GMP activities
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Identification of CQAs and CPPs and their ranges (ICH Q8)
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Equipment qualification (FAT, SAT, IQ, OQ, PQ)
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Process flow diagrams
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Contamination Control Strategy (Annex I)
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Risk analysis, FMEA
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Gap analysis for process and method transfers
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QA documentation
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Tech transfer project management
Support of API and drug product registrations
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Registration strategy
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Analytical method development, optimisation and validation
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ASMF and registration dossier gap analysis
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ASMF and registration dossier compilation
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Support of the registration process
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Help with preparation of answers to deficiency letters (including experimental support)
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Project management
Support of computer and automated systems under GMP according to FDA, EMEA, and MHRA requirements
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Computerised system validation
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Validation of automated and electronic devices (commissioning, design qualification)
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Assessment of computerised systems compliance with 21 CFR Part 11
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Data integrity (ALCOA, ALCOA+) within cGMP and GLP environment
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QSR (Quality System Regulation) evaluation with focus on computerised system validation, software (VMP, testing, change management, incident management, etc.)
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IT infrastructure qualification
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Validation/qualification in the XaaS environment
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Vendor assessment with focus on CSV and IT infrastructure
Trainings:
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Computer system and spreadsheet validations (MS Excel)
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Data integrity
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Validation of equipment containing software (e.g., lab equipment)