PV - Set - Go... - Navitas Life Sciences

FUTURE-READY PATIENT SAFETY UTILIZING A BLEND OF PEOPLE, PROCESS, AND TECHNOLOGY TO DELIVER THE FULL SPECTRUM OF PHARMACOVIGILANCE

At Navitas Life Sciences our experienced Pharmacovigilance (PV) Consulting team aid organizations in building and implementing global future-ready PV systems. Backed by insights from our industry-leading PV networks, pvnet^®, pvconnect^®, pvtech^®, and pvindia^®, we empower our clients to make informed decisions on how to build a future-ready PV organization and achieve strategic objectives faster by incorporating our proven best practices.

We understand the difficulties faced by emerging pharmaceutical companies as they move towards post-marketing, and have worked to simplify the most common PV Service requests, budget, and timeline into our PV - Set - Go offering as we work to deliver the fundamentals of implementing a PV system in a cost effective manner.

ARE YOU LOOKING TO BUILD YOUR PHARMACOVIGILANCE SYSTEM FROM SCRATCH?

Through insight-driven assessments and regulatory understanding, our proven framework allows clinical stage organizations to quickly prepare for the demands of post-marketing. Following a robust assessment process, our team provides a comprehensive report outlining the effectiveness of the current PV system in key areas including: Compliance, Capabilities, and Technologies. In addition, the report presents expert recommendation(s) for the improvement and design of a future-ready, fit-for-purpose PV system.

When should we start implementing our PV System?

In short, it’s never too soon! Clinical stage companies should consider their PV system as early as possible. It can take time to implement an effective PV system and delaying the build of your PV function into phase 3 can introduce significant risk to regulatory approval.

Top considerations

Navigating the regulatory requirements where the product(s) will be marketed; global authorities require a trained network of Qualified Persons who can work with local and regional regulators
Headcount, skills, and capabilities needed for core PV capabilities and how to source to avoid risk of non-compliance
Harmonized Standard Operating Procedures (SOPs) and process - establishing written documentation of procedures to create efficiency and ensure that people, process, and technology are aligned
Marketing Authorization Holders (MAHs) must have a detailed plan and clear understanding of how they will receive, aggregate, and report safety information. A Pharmacovigilance System Master File (PSMF) may also be required by certain markets
Effective selection of tools, including the right safety database for your organization, to complement workflows
Developing an inspection-ready Quality Management System (QMS)

PV - Set - Go delivers:

PV Readiness Assessment

Providing a clear roadmap for a future-ready, fit-for-purpose PV system

A comprehensive assessment to understand your current PV system compliance gaps
Recommendation(s) for fit-for-purpose improvements that ensure regulatory requirements are met
Strategic roadmap to achieving PV business objectives

Tailored PV Operating Model

Delivering an optimized organization structure and governance model

An optimal resourcing model to meet the capability requirements required to support core PV operations
Identification of opportunities and potential partners for outsourcing and offshoring non-core transactional activities
Define, source, and establish a trusted network of QPPVs to support global requirements

Technology Assessment and Roadmap

Helping your organization achieve more by leveraging NextGen technology solutions and systems

Navigating the vendor landscape with an in-depth evaluation of multi-tenant vs. single tenant safety database options
Benchmarking current technology against industry best practice(s) and the market landscape
Providing a business case for IT investment

Quality Management System Development

Ensuring Regulatory Compliance through a harmonized Standard Operating Procedure (SOP) framework

Establishing SOP governance to drive strategic alignment with business, content owner, cross-functional business, and technology
Developing a simplified document framework and aligned structure
Authoring and updating SOPs

Start your journey towards becoming a compliant and successful post-marketing organization with our assessment and find out how PV – Set - Go can support your organization.