Pharmacovigilance System Enhancement

CHALLENGE

Preparing for and Managing Inspections

CHALLENGE

Leveraging of Safety Data to Inform Product Strategy and Support Business Objectives

CHALLENGE

Ensuring Current Standards In An Evolving Regulatory Environment

CHALLENGE

Integrating PV Systems and Data in the Post-Merger Setting

SOLUTION

Manage and Support Remediation Tactics

Prepare the organization and employees for inspection and support inspection operations, as well as responses

SOLUTION

Communicate Conclusions and Learnings that Differentiate

Support development of safety stories that differentiate products based on safety profiles; Propose strategies for effective methods of communication of safety data

SOLUTION

Develop a Robust Long-term Strategic Plan for PV

Devise a plan that includes capital expenditures as well as skill development to ensure that the company is keeping pace with applicable regulatory requirements and industry standards

SOLUTION

Evaluate Gaps and Potential Risks

Create and execute a comprehensive integration plan to maintain business continuity and uphold patient safety standards while mitigating risk

+ CHALLENGE - Preparing for and Managing Inspections

SOLUTION - Evaluate Gaps and Potential Risks

Create and execute a comprehensive integration plan to maintain business continuity and uphold patient safety standards while mitigating risk

+ CHALLENGE - Leveraging of Safety Data to Inform Product Strategy and Support Business Objectives

SOLUTION - Manage and Support Remediation Tactics

Prepare the organization and employees for inspection and support inspection operations, as well as responses

+ CHALLENGE - Ensuring Current Standards In An Evolving Regulatory Environment

SOLUTION - Communicate Conclusions and Learnings that Differentiate

Support development of safety stories that differentiate products based on safety profiles; Propose strategies for effective methods of communication of safety data

+ CHALLENGE - Integrating PV Systems and Data in the Post-Merger Setting

SOLUTION - Develop a Robust Long-term Strategic Plan for PV

Devise a plan that includes capital expenditures as well as skill development to ensure that the company is keeping pace with applicable regulatory requirements and industry standards