Quality Management and Regulatory
Appropriate quality and oversight and regulatory compliance is critical to assure patient safety and scientific integrity. CITRAS understands pharma and regulatory expectations of a robust quality management system. Recent changes such as the revised expectation on aseptic manufacturing provided in the update to Annex 1 and the ongoing focus on data integrity require appropriate demonstration of quality controls. Whether it is support with new site setup, updates to existing quality programmes or providing assistance with quality investigations and CAPA development or training, CITRAS can help.
Quality and Regulatory
An overview of the areas which CITRAS can support can be found below:
Quality Management
QMS selection
URS development
Policy/Manual/SOP/WID development
Site master file development
Contamination control strategy development
Validation Management
Risk management
Change management
Vendor qualification management
Root cause investigation management
CAPA recommendations
Training
Inspection and audit readiness
Regulatory
Non-clinical studies
Drafting of CMC section
GxP expectations (US/EU/JP)
RDRC vs IND
IMP vs Specials (UK)
Regulatory submissions
Our Services
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