Compliance Program Design And Implementation
Compliance in the Pharmaceutical Industry
Ensuring Compliance and Ethics Governance in Pharma and Medical Devices
In the ever-changing world of pharmaceuticals and medical devices, maintaining compliance and ethics governance is necessary for long-term business operations. Companies must follow tight regulatory regulations to protect patient safety, maintain compliance ethics and business integrity, and reduce the consequences associated with noncompliance. Eunomia Pharma Services specialises in healthcare compliance services, helping organisations develop strong governance frameworks, automate compliance procedures, and perform strategic risk assessments. Our experience in medical device compliance and pharmaceutical regulations enables firms to confidently traverse complicated compliance environments.
EU Pharmaceutical Compliance Training and Monitoring
Effective training and monitoring are essential aspects of compliance in the pharmaceutical industry. Our specialised EU pharmaceutical compliance training programs provide organisations with the information and resources they need to guarantee regulatory compliance and ethical decision-making.We offer compliance workflow automation and monitoring solutions through Veeva Suite and Salesforce that improve overall productivity and business intelligence. Power BI and Tableau analytics are also incorporated into our response and compliance monitoring services which enhance the services provided. By combining compliance automation and proactive governance, we enable firms to maintain transparency and responsibility across all processes.
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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