Compliance Program Design And Implementation
We can be your trusted partner to support with the strategic and operational elements of all the elements of a compliance program including but not limited to:
- Monitoring
- Risk Assessment
- Maturity Assessment
- Incident/ CAPA Management
- Building governance framework for global and country specific systems and processes (e.g., UK, ROI) and ensure that the processes are automated and simplified, where possible.
- Supporting the business with challenging and innovative initiatives like pre-license scientific exchange, advisory boards, Budget Impact Models (BIM) and building an Omnichannel platform.
- Managing and defending complaints from the PMCPA, other European Regulators and put the relevant corrective actions and trainings in place to minimise future complaints
- Streamlining processes via any Electronic Document Approval System e.g., Veeva Suite of Processes, Salesforce, etc.
- Compliance Processes Automation via Sharepoint, Power Automate and Power Apps.
- Materials, Meeting Review & Certification/ Promotional Compliance
Data Analytics
- Compliance Data Analytics including Power BI, Tableau.
- Applying Data Analytics to improve Compliance Monitoring Program in order to better prevent, detect, and respond to both current and evolving risks.
We take pride in being a trusted partner to the pharmaceutical industry, offering expert guidance and solutions that promote compliance and uphold ethical values.
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