Gap Analysis and Consulting

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Identifying a specific customizable model that matches the needs and strategy of the organization, is an important first step in this process. Vigilare  offers various options with flexible staffing from short-term tactical support to long-term strategic partnerships.

Vigilare’s Gap Analysis and Consulting Expertise

Local Affiliate Pharmacovigilance Services

 

We help companies navigate complex regional and local pharmacovigilance regulatory requirements to streamline expansion to new markets, facilitate growth in current markets, and gain workload flexibility without compromising quality.

 

  • Affiliate PV full scope of services

    • Provision of LPPV/Local QPPV/LSR and deputies
    • 24/7 availability where required plus multiple language coverage
    • National point of contact with local health authorities
    • Creation and maintenance of local PV systems ( local PSMF/SOPs)
    • Local literature screening, where required
    • Local ICSR management (intake/processing/reporting/tracking) Submission of domestic/foreign ICSRs to competent authorities
    • Preparation and submission of PSURs and risk management plans
    • Training in medicinal product SmPC content & HCP interaction
    • Risk management plans and local implementation of RM material
    • Educational materials
    • DHCP communications
    • Local PV legislation monitoring and proactive customer updates
    • Support and participation in PV inspections and audits
    • Local PV quality management support and training for local affiliates
    • Local signal detection
    • Medical Information services

Local QPPV Representative services

Our key services include:

  • EU QPPV services:Providing a central, qualified contact to oversee PV systems and ensure compliance within the European Union.
  • UK QPPV services:Meeting the distinct requirements for pharmacovigilance oversight in the UK.
  • Local PV representatives:Delivering region-specific PV support to ensure compliance in local markets.
  • 24/7 availability:Ensuring around-the-clock support for adverse event reporting and regulatory queries.
  • Audit and inspection readiness:Preparing your PV systems for audits and regulatory inspections.

Pharmacovigilance Audits

Vigilare’s organization ensures global delivery of all Pharmacovigilance  audit services. We are the first-choice provider of Pharmacovigilance audits for many pharmaceutical companies around the world. At Vigilare, auditors are highly qualified with necessary and long-standing expierence as well as strong cultural awareness and excellent communication skills to effectively conduct and/or participate in PV audit activities.

Our Pharmacovigilance Audit Services

Vigilare offers a full range of Pharmacovigilance audits services in line with GVP requirements and global regulations. Our team accompanies you from the designing and implementation of PV audit system to follow-up activities and support in case of inspections.

Design and implentation of PV audit system:

  • Support for defining and implementing risk-based audit strategy
  • PV audit risk analysis
  • Preparation and management of PV audit program
  • Preparation and management of PV audit questionnaire

PV audit support:

  • PV system GAP analysis
  • PV audits at or on behalf of client company:
  • PV System internal audits
  • Affiliate audits
  • License partner/distributor audits
  • Qualification of PV vendor audits
  • Process audits (PSMF, RMP, PSUR…)
  • Due diligences
  • PV inspections support

Follow-up activities:

  • Preparation, management and follow-up of CAPA plan related to PV audits or inspection

Qualified Person for Pharmacovigilance (QPPV)

The Vigilare EU-QPPV is located in one of the EU/EEA Vigilare offices and fluent in English language. The QPPV has extensive experience in establishing and maintaing the MAH’s Pharmacovigilance System including profound knowledeg and full understanding on all tasks related to Pharmacovigilance. Besides the nominated Deputy QPPV, back-up arrangements to ensure the 24/7/365 availability of the QPPV are also done via an internal QPPV call-system.

Key tasks of the EU-QPPV include

  1. Implementation and maintenance of a functional and compliant pharmacovigilance system;
  2. Ongoing monitoring of the benefit and risks of medicinal products, including overview of medicinal safety profiles and any emerging safety concerns;
  3. Review and oversight of the product Risk Management Plans, including any resulting risk minimization measures and any other conditions or obligations adopted as part of a marketing authorization and/or other commitments relating to safety or safe use of a medicinal product;
  4. Maintenance of the Pharmacovigilance System Master File
  5. Serving as point of contact to Regulatory Authorities with 24 hours availability, ensured via a Vigilare QPPV call-system

Facts to Focus

Device Applications
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Testimonials

Partnering with Vigilare for pharmacovigilance services has been a game-changer. Their team is proactive, detail-oriented, and consistently on top of safety updates and regulatory changes across Europe. It’s rare to find such a dependable partner who treats compliance as seriously as we do.
EU-based Biotech Company
EU-based Biotech CompanySenior PV Manager
We rely on Vigilare for global pharmacovigilance support across multiple regions. They understand the nuances of each market and consistently deliver accurate, timely, and compliant safety reporting. It’s been a relief having such a competent team on board.
Safety & Risk Management Lead
Safety & Risk Management LeadMultinational Vaccine Manufacturer
Vigilare’s post-marketing support has helped us maintain compliance seamlessly in the US market. Their responsiveness and structured reporting systems made it easy to keep pace with regulatory expectations. Their clarity and ownership stand out.
Director, Regulatory Affairs,
Director, Regulatory Affairs,US-based Pharmaceutical Company
We engaged Vigilare during a critical vaccine rollout phase. Their insights into regulatory processes in the Middle East, combined with their ability to coordinate across regions, ensured smooth approvals and timely submissions. They truly acted like an extension of our team.
Regulatory Affairs Head
Regulatory Affairs Head Gulf-based Public Health Organization
Vigilare has been instrumental in supporting our medical device registrations in both the US and European markets. From preparing the technical documentation to navigating CE and FDA submissions, their expertise made a complex process feel manageable and well-guided.
Global RA Manager, Affairs Head
Global RA Manager, Affairs HeadMedTech Company

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