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

• Identification of CQAs and CPPs and their ranges (ICH Q8)

• Equipment qualification (FAT, SAT, IQ, OQ, PQ)

• Process flow diagrams

• Contamination Control Strategy (Annex I)

• Risk analysis, FMEA

• Gap analysis for process and method transfers

• QA documentation

• Tech transfer project management

Support of API and drug product registrations

• Registration strategy

• Analytical method development, optimisation and validation

• ASMF and registration dossier gap analysis

• ASMF and registration dossier compilation

• Support of the registration process

• Help with preparation of answers to deficiency letters (including experimental support)

• Project management

Support of computer and automated systems under GMP according to FDA, EMEA, and MHRA requirements

• Computerised system validation

• Validation of automated and electronic devices  (commissioning, design qualification)

• Assessment of computerised systems compliance with 21 CFR Part 11

• Data integrity (ALCOA, ALCOA+) within cGMP and GLP environment

• QSR (Quality System Regulation) evaluation with focus on computerised system validation, software (VMP, testing, change management, incident management, etc.)

• IT infrastructure qualification

• Validation/qualification in the XaaS environment

• Vendor assessment with focus on CSV and IT infrastructure

Trainings:

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• Computer system and spreadsheet validations (MS Excel)

• Data integrity

• Validation of equipment containing software (e.g., lab equipment)