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LATAM Pharmacovigilance

National system

imagen 

The team at FP CLINICAL PHARMA can help your company in developing a GOOD PHARMACOVILIGANCE PRACTICES PROGRAM according to your specific needs.
The THE GOOD PHARMACOVILIGANCE PRACTICES PROGRAM was designed as a quality system based on national and international guidelines and includes the investigation, detection, assessment, validation, monitoring, reporting and archiving of adverse events of the products during commercialization.



Service Packs

BÁSICO

Management of adverse events

Notification report

24/7 communication

Out-of-office professionals

Use of the F.P. Platform VigiPharma

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SUPERIOR

Safety information

In-house training and workshops

Prospect Review

Preparation for audits and inspections

Security agreements between companies

Updating of the organizational and documentary structure

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CONSULTANCY

Good pharmacovigilance practices

Implementation of Quality system in Pharmacovigilance

Carrying out training

Review and Analysis of Management Plans

Modification of prospects

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SPECIALS

Preparation of Security Reports (IPS / PSUR / PBRER)

Risk Management Plans (PGR / RMP)

Active Pharmacovigilance Plans

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Services

Qualified Persons Responsible for Pharmacovigilance (QPPV)

Pharmacovigilance System Master File

Individual case safety Reports

Clinical Safety

Aggregate Reports

Global Literature Reports

Benefit-Risk Analysis

Medical Writing

Risk Management Planning

Company Core Safety Information

Develop in house PV systems/SOPs/ PSMF/QMS

PV Training

Audits and inspection preparation

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Professionals of our staff will attend giving all necessary advice.

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+54 11 4775-2640 / 2869

Since 2003, with recognized credentials, our primary objective has been to provide the Local and International Industry with Clinical, Pharmacological, Regulatory, Bio Analytical and Statistical...

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Contact us
  • Juncal 4484 3º (C1425BAB)
    Palermo - Cap. Fed.
    República Argentina
  • Tel.: +54 11 4775-2640
  • Tel.: +54 11 4775-2869
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