Our team of QA experts offers comprehensive Audits to evaluate the manufacture compliance with GMP in all aspects of Production and Quality Control.
We also offer Vendor Management Model, Vendor Audits, Vendor Questionnaires, System Design.
•Establish IMP batch documents for a variety of studies including double blind, randomised and cross over studies
•Provision of a QP Declaration to meet Regulatory submission requirements.
•Establish Product Specification File (PSF)
•Review and agree Clinical Label Texts, Primary & Secondary labels
•Management of Returns following completion of study
•Help with Clinical Complaints, Temperature Excursions Handling
•Supply chain management of Clinical Trial materials