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Regulatory Affairs
Medical writing, Non-clinical modules, Gap analysis
A Medical Writing project covering nine non-clinical modules (m2.4) for two products in different pharmaceutical forms and dosages.
Pharmacovigilance
Clinical Safety, Clinical Trials
Supporting an American pharmaceutical company with safety and efficacy in clinical trials
Auditing & QA
Project management, Gap analysis, Documentation
A proactive approach to passing a PV audit. Th2
Regulatory Affairs
Automation, Process improvement
Providing transparency on request status, time spent on each request, speeding processes and reducing error.