Our consultants reviewed the registered details against manufacturing site documents, highlighting compliance issues, and also worked with site QA departments in preparing remediation plans for each licence. Over 600 licenses were reviewed and each phase of the project was delivered to the client's timelines.
Pharmalink exceeded the client's expectations on each phase of the project, which resulted in the client engaging Pharmalink to prepare all of the Variations and submit to all EU agencies in order to bring the product licences into compliance.
