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Safety System Strategic Consulting

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Plan your Long-Term Success with our Drug Safety Strategic Consulting Services

Safety Systems and information technology is an integral part of setting-up and running effective Pharmacovigilance operations for all pharmaceutical and biotech companies, regardless of their size.

Techsol’s Pharmacovigilance team members have several years of experience in advising and providing strategic support on business process for all kinds of customers such as emerging/ SMB, generic, innovators, large global pharma and CRO companies. Our strategic consulting services coupled with our technology solutions help setup and running operations of the drug safety – Case Management, Aggregate Reporting, Signal Management, Risk Management and Digital Operations.

How We Can Help

Our pharmacovigilance technology and process SMEs and technology experts work collaboratively with you to help in the following areas:

PV Technology Selection

  • Evaluate business goals, challenges and set measurable value gain targets
  • Provide assistance in selecting the right vendor and technology solution
  • Prepare long-term strategic Pharmacovigilance integrated Technology Roadmap
  • Advise on scalable and secure system architecture design
  • Conduct business fit-gap analysis
  • Define implementation path for modern technology solutions involving Artificial Intelligence and Data Science

Regulatory Compliance Fulfillment Advisory

  • Map compliance objectives to the actual pharmacovigilance business processes
  • Formulate a PV Compliance and Risk Governance Framework
  • Enable process owners and business groups to stay updated with latest updates in regulations
  • Ensure systems and business processes are implemented and managed in compliance with all applicable regulations.
  • Perform system and process audits of vendor supplied and legacy systems and aid in addressing any compliance issues that are found

PV Systems and Process Optimization

  • Assist in developing process artifacts such as SOPs, policies and reports related to operations, change management, regulatory reporting, auditing, and compliance management
  • Expanding the usage of existing system capabilities through upgrades or potentially employing new solutions to bridge gaps to be scalable to conform with the changing nature of the organization’s product portfolio and growth aspirations

Other Areas:

  • In addition, our team can also assist you in vendor selection for case processing, data privacy adherence requirements, cloud compliance and assurance etc.
  • We offer operational assistance related to Mergers and Acquisitions, localization of PV functions (such as Japan or South Korea operations), commercialization, product launch, affiliate management etc.
  • Assistance and representation at Regulatory Inspections and all kinds of Audits
  • Streamline and track compliance management of Safety Agreements (SA) or Safety Data Exchange Agreements (SDEA)

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