Function Dynamics
The pharmaceutical and device industries face an array of steadily growing pressures, including increasing concerns about product safety. Healthcare product and service providers also recognize that safety issues can have a significant impact including regulatory fines, litigation costs, and reduced market share. As a result, concerns about safety are leading companies to improve their PV capabilities, are driving rigorous regulatory scrutiny, especially during the approval process, and new rules require PV to expand its role.
read more
Business Challenges
While most companies are working to address new requirements for PV groups, many face considerable challenges to increase capabilities and expand the traditional scope of PV activities. PV groups must be able to develop and define the type of structures and communications necessary to integrate safety information across the pre- and post-market spectrum. A greater challenge will be in implementing a cross-functional plan that enables PV to expand into an effective proactive role.
read more
Our Depth of Knowledge
Success in today’s marketplace requires both great strategy and an integrated, proactive approach to the design and management of pharmacovigilance and risk management systems to make that strategy come alive. Over the last 20 years we’ve helped clients in a wide variety of industries address both the "what" of strategy and the "how" of implementation. Our services are intended to help clients design or redesign and implement systems that enable strategically important performance in the organization. And we help Pharmacovigilance leaders build departments capable of delivering on their value proposition.
read more
|