Full QPPV
Services

Global Network, Local Experts

A NETWORK OF EXPERIENCED QPPVS FOR GLOBAL AND LOCAL QPPV NEEDS

A Qualified Person for Pharmacovigilance (QPPV) is personally responsible, by law, for the safety of the human pharmaceutical products marketed by that company in the EU. The QPPV should reside in the EU and provide support across the globe through in-house QPPVs and a network of Local QPPVs.

When choosing a QPPV partner, it is important to select a partner with access to the best local experts, and who can provide scalable and customized solutions based on specific needs. Navitas Life Sciences provides integrated and end-to-end solutions that extend beyond QPPV and include comprehensive management of safety reporting, lucid communications, and effective support to all stakeholders.

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Essential Role of QPPV

Focus on PV

Maintaining and establishing a PV system in the EU

Safety First

Monitoring safety of the drug products of the MAH

Follow Legislation

Coordinating actions based on local legislations

Sole Contact

Serving as the single point of contact for Competent Authorities (24/7)

Audits and Inspections

Monitoring and Compliance – Audits and Inspections

Are you looking to outsource the role of your QPPV?

At Navitas Life Sciences, we have a well-established network of local QPPVs who are helping our clients to meet specific local PV requirements.

Advantage of Outsourcing the QPPV role to Navitas Life Sciences

Right Expertise with optimal infrastructure

A global network of experienced EU and local QPPVs

Cost-effective and efficient support

Ability to scale to suit specific pharmacovigilance needs

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Our End-to-End QPPV Services include

Leveraging some 30+ years of PV experience, you can be assured that we have both the expertise and the infrastructure to support your business to ensure Patient Safety and compliance.
Availability of QPPV and Local QPPV with appropriate back-up for EU and the UK as needed per local HA requirements
24/7 Point of Contact for Competent Authorities, including back up QPPV for EU/locally as needed
Preparation, Maintenance, and Review of PSMF
Ongoing monitoring of local safety parameters: Aggregate Reports, Signals, Benefit and Risks of MAH products

Tailormade Solutions to Cater to your Unique Needs

MAH can outsource the function of the QPPV as per need. This could range from a few hours per month and additional hours of QPPV consulting to a full QPPV office with a QPPV, deputy QPPV, and administrational support. Solutions are based on your portfolio and geography, with customizable solutions based on your specific needs.
Initial QPPV Set-Up

Initial QPPV Set-Up

The setting up of a QPPV Office, nominations to Competent Authorities, and related documentation
Monthly Retainer

Monthly Retainer

This model includes a set of routinely performed activities by our QPPVs on a monthly basis
Additional and Ad-hoc Activities

Additional and Ad-hoc Activities

Such activities may be out of scope, but can be executed with client consent

Initial QPPV Set Up

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Monthly Retainer

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Additional and Ad-hoc Activities

We appreciate that additional and ad-hoc activities arise, and we are happy to support your requirements when they do. Such work is invoiced on an hourly basis as needed. In our experience, such activities may include, but are not limited to:

  • Registration CA as MAH’s EU-QPPV and/or Local QPPV
  • Develop/adapt/update/inputs/consultation of/to MAHs PSMF (or local) and its sub files and applicable SOPs
  • Participation in MAH training, teleconferences, face-to-face meetings, and handling of CA/MAH/HCP requests
  • Participate and/or deliver Project specific training to customer/distributors
  • Product quality complaints management (translations: to/from English, QC, form filling, QC of filled information, duplicate check and tracking, reporting to CA or Client)
  • Processing of identified literature safety information (translation, filling form, sending to MAH), including follow-up activities
  • Local RMP related activities and/or risk minimization implementation activities
  • Submission of foreign safety reports to CA
  • Collection and exchange of CA questions/requests and replying to local medical enquiries
  • Participation in audits/inspections, CAPA/deviation management
  • Patient Support/Patient Oriented/PASS/PAES activities - protocol design review, tracking
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