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Services

Consulting services in Pharmacovigilance for the Pharmaceutical Industry. From global activities to local partner functions in Spain. Local Contact Person for Pharmacovigilance (LCPPV, LPPV, Local QPPV). GVP Audits. Consultant Pharmacovigilance expertise and resources.

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Pharmacovigilance Audits
(GVP Audits)

We perform GVP audits to review the compliance of your pharmacovigilance system or your partner’s PV systems:

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  • Internal GVP Audits

  • GVP Audits to Distributors and Partners

  • GVP Audits to Vendors and CROs

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Pharmacovigilance - Global Services

We can help your company from the establishment of the pharmacovigilance system to the provision of advanced pharmacovigilance services

  • SOP Development. From Clinical stages to the Post-Marketing setting.

  • Adverse Event (AE) Reporting Company Policies.

  • Key Performance Indicators (KPI) and Metric Development. Compliance with GVP and PSMF requirements.

  • Compliance Monitoring and Vendor Oversight.

  • CAPA and Deviation Management.

  • Audit and Inspection readiness.

  • Pharmacovigilance Training. Basic PV Training for Company staff, extended PV Training for Scientific or Medical Representatives. Training for new employees, Vendors and Annual Refresher Trainings.

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Pharmacovigilance Consultant Support

We support your Pharmacovigilance unit providing consultant resources:

  • Pharmacovigilance extensive expertise

  • Hands-on support filling the gaps

  • Solve peaks of workload, interim coverage or backlogs

  • Free up resources from your team

  • Short or long-term collaboration

  • Added-value to your department

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Local Contact Person For Farmacovigilance (LCPPV Spain)

We can be your pharmacovigilance partner in Spain, providing the legally required role of the Local Contact for Pharmacovigilance (LCPPV):

  • Local Contact Person for Pharmacovigilance (LCPPV, LCPV). LPPV, Local QPPV. Local Responsible Person for PV. 

  • Deputy LCPPV

  • Combined coverage of main LCPPV + Deputy LCPPV

  • Local Literature Monitoring (LLM, LLS)

  • Regulatory Intelligence Monitoring on the Spanish Agency of Medicines and Medical Devices (AEMPS).

  • ICSR Local Management. Collection and Follow-up.

  • Adaptation and submission of Educational Materials for Additional Risk-Minimization Measures.

  • Risk Management Plan adaptation.

  • Local Affiliate PV Training

  • Vendor PV Training

 

Check our blog entry about the LCPPV role in Spain.

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