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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

 
      Last update: 31.08.2015