Services
 

QUALITY ASSURANCE

GMP auditing (suppliers, contractors)
Self-inspections (internal compliance audits)
Qualified Person (Austria and Germany)
Temporary Head of QA
Project management
Quality assurance*

REGULATORY COMPLIANCE

Preparation & review CMC Module 2.3, Module 3
Assistance responding to deficiency letters

CLINICAL RESEARCH

GCP auditing
Monitoring

* Possible services within the range of quality assurance

●  Set-up of quality systems

●  PQR preparation

●  Preparation, review & approval of validation documentation

●  Preparation, review & approval of stability documentation

●  Review & approval of master batch records

●  Preparation of SOPs

●  Supplier qualification

●  Change control management

●  Deviation management

●  Complaint handling

●  CAPA management

●  Batch record review

●  GMP training

●  Documentation management

… and many more services in quality assurance