Audits Department

Worldwide compliance assurance

About the department

What do we do?

Experienced auditors with strong background in the audit reference standards. We provide assurance of compliance through a wide range of areas of expertise.

Why?

To qualify your suppliers, mitigate risks and identify areas of improvement in your own systems and ensure operations, documents and processes meet the required quality standards.

Pharmacovigilance Audits

Internal audits;
Audits to contractors.

GMDP Audits

GxP audits to suppliers, distributors and CMO’s;
Internal audits.

GCP Audits

Investigator Site, Sponsors and IMP manufacturers audits;
Critical Document Audits (e.g CT Protocol, CRFs).

Regulatory Audits

MA dossiers audits;
Process compliance.

Get to know our
Audits team

Medical & Scientific

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Quality Assurance

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Pharmacovigilance

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Audits

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What we do in the M&S Department

Clinical

Clinical & Non-Clinical CTD modules;
Clinical Addendum;
Text preparation and revision (SmPC and PIL);
Readability tests and bridging reports;
Similarity reports.

Medical

Preparation and review of promotional and non-promotional materials;
Preparation of abstracts, manuscripts, posters and presentations;
Scientific translations;
Advisory boards and roundtables;
Medical inquiries management.

Toxicology

Toxicological reports;
Environmental Risk Assessment (ERA) reports;
Permitted Daily Exposure (PDE) calculation reports.

M&S Team

Our Medical & Scientific team

Bernardo Gameiro

Regulatory Affairs Junior Officer

Regulatory Affairs Department

Francisca Ataíde

Quality Assurance Junior Officer

Quality Assurance Department

Matilde Pina

QUALITY ASSURANCE SENIOR OFFICER

Quality Assurance Department

Ester Oliveira

PHARMACOVIGILANCE JUNIOR OFFICER

Pharmacovigilance Department

Juliana Salvado

Pharmacovigilance Junior Officer

Pharmacovigilance Department

Tatiana Graça

ADMINISTRATIVE JUNIOR OFFICER

Support

Mariana Oliveira

Pharmacovigilance Junior Officer

Pharmacovigilance Department

Nathália Santana

Quality Assurance Officer

Quality Assurance Department

Gustavo Sousa

Auditor GxP

Audits Department

Beatriz Santos

Quality Assurance Junior Officer

Quality Assurance Department

Verónica Pinho

Medical & Scientific Junior Officer

Medical & Scientific Department

Ana Rita Cordeiro

Pharmacovigilance Junior Officer

Pharmacovigilance Department

Daniela Vieira

Regulatory Affairs Junior Officer

Regulatory Affairs Department

Bruno Pedro

Medical Advisor

Pharmacovigilance Department

Helena Marques

REGULATORY AFFAIRS SENIOR MANAGER

Regulatory Affairs Department

Érica Nunes

Pharmacovigilance Senior Officer

Pharmacovigilance Department

André Luz

Quality Assurance Director

Quality Assurance Department

Ricardo Andrade

Auditor PhV

Audits Department

César Gonçalves

Auditor GxP

Audits Department

Gabriel Alves

Auditor GxP

Audits Department

Cristina Serra

Auditor GxP

Audits Department

Lara Santos

Quality Assurance Officer

Quality Assurance Department

Gabriel Alves

Quality Assurance Associate Director

Quality Assurance Department

Bruno Pedro

Medical Advisor

Medical & Scientific Department

Andreia Mónico

Medical & Scientific Manager

Medical & Scientific Department

Lígia Ferreira

Medical & Scientific Director

Medical & Scientific Department

Daniela Gomes

Pharmacovigilance Manager

Pharmacovigilance Department

Ricardo Andrade

EU QPPV

Pharmacovigilance Department

Mariana Rocha

Pharmacovigilance Director

Pharmacovigilance Department

Bárbara Macedo

Regulatory Affairs Senior Officer

Regulatory Affairs Department

Gina Abreu

Regulatory Affairs Junior Officer

Regulatory Affairs Department

Guilherme Monteiro

Regulatory Affairs Junior Officer

Regulatory Affairs Department

Adriana Alves

Regulatory Affairs Junior Officer

Regulatory Affairs Department

Dania Shriki

Regulatory Affairs Officer

Regulatory Affairs Department

Libânia Alves

Regulatory Affairs Officer

Regulatory Affairs Department

Marta Almendra

Regulatory Affairs Officer

Regulatory Affairs Department

Elsa Morgado

Regulatory Affairs Officer

Regulatory Affairs Department

Polina Pastoukhova

Regulatory Affairs Officer

Regulatory Affairs Department

Inês Penedones

Regulatory Affairs Officer

Regulatory Affairs Department

Beatriz Matias

Regulatory Affairs Senior Officer

Regulatory Affairs Department

Nuno Canoeiro

Regulatory Affairs Senior Officer

Regulatory Affairs Department

Rita Henriques

Regulatory Affairs Senior Officer

Regulatory Affairs Department

Alexandra Miranda

Regulatory Affairs Senior Officer

Regulatory Affairs Department

Rita Agrela

Regulatory Affairs Manager

Regulatory Affairs Department

Ana Teresa Martins

Regulatory Affairs Manager

Regulatory Affairs Department

Duarte Jesus

Regulatory Affairs Manager

Regulatory Affairs Department

Raquel Miguéis

Regulatory Affairs Associate Director

Regulatory Affairs Department

Frederico Nunes

Regulatory Affairs Associate Director

Regulatory Affairs Department

Mariana Pinto

Business Development Junior Officer

Support

Eva Faria

Compliance Senior Officer

Support

Andreia Ferreira

MEDICAL & SCIENtiFIC OFFICER

Medical & Scientific Department

Diana Oliveira

Administrative Manager

Support

Ana Margarida Andrade

Regulatory Affairs Director

Regulatory Affairs Department

Sara Oliveira

Medical & Scientific Manager

Medical & Scientific Department

Ana Rita Félix

Medical & Scientific Manager

Medical & Scientific Department

Margarida Tapadas

Quality Assurance Junior Officer

Quality Assurance Department

Carolina Pinto

Quality Assurance Junior Officer

Quality Assurance Department

José Rolim

Quality Assurance Officer

Quality Assurance Department

Catarina Mestre

Quality Assurance Officer

Quality Assurance Department

Marco Correia

Quality Assurance Senior Officer

Quality Assurance Department

Mariana Silva

Quality Assurance Manager

Quality Assurance Department

Inês Melo

Quality Assurance Senior Officer

Quality Assurance Department

Rafaela Schouten

Quality Assurance Manager

Quality Assurance Department

Ricardo Andrade

Managing Director

Managers

André Luz

Auditor GxP

Audits Department

César Gonçalves

Managing Director

Managers

José Gomes

Audits Director

Audits Department

Beatriz Viegas

Pharmacovigilance Junior Officer

Pharmacovigilance Department

Carolina Mesquita

Pharmacovigilance Junior Officer

Pharmacovigilance Department

Tânia Salvador

Pharmacovigilance Officer

Pharmacovigilance Department

Bruna Monteiro

Pharmacovigilance Officer

Pharmacovigilance Department

Sara França

Pharmacovigilance Manager

Pharmacovigilance Department

Sofia Antunes

Pharmacovigilance Manager

Pharmacovigilance Department

Ana Isabel Sousa

Pharmacovigilance Manager

Pharmacovigilance Department

Catarina Calado

Pharmacovigilance Senior Officer

Pharmacovigilance Department

Ana Cristina Silveiro

Pharmacovigilance Senior Officer

Pharmacovigilance Department

Rita Figueiredo

Pharmacovigilance Senior Officer

Pharmacovigilance Department

Ana Santos

Pharmacovigilance Officer

Pharmacovigilance Department

Sofia Santos

Pharmacovigilance Officer

Pharmacovigilance Department

Joana Fernandes

Pharmacovigilance Officer

Pharmacovigilance Department

In-house developed Audit Report & Planning Platform

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AuditSearch

In-house developed

Audit Report & Planning Platform

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Meet our team

Medical & Scientific

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Quality Assurance

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Pharmacovigilance

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Audits

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AuditSearch

PVSEARCH is a validated data management system developed by Owlpharma, aiming to support the medical literature screening activities. This platform was developed by our PhV professionals and designed to fit GVP requirements, and the experts needs.

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Audits Department

Worldwide compliance assurance

About the department

What do we do?

Experienced auditors with strong background in the audit reference standards. We provide assurance of compliance through a wide range of areas of expertise.

Why?

To qualify your suppliers, mitigate risks and identify areas of improvement in your own systems and ensure operations, documents and processes meet the required quality standards.

Pharmacovigilance Audits

GMDP Audits

GCP Audits

Regulatory Audits

Medical & Scientific

Quality Assurance

Pharmacovigilance

Audits

More

What we do in the M&S Department

Clinical

Medical

Toxicology

Medical & Scientific

Quality Assurance

Pharmacovigilance

Audits

More

No spam. Notifications only
aboutnew products and
updates. You can always
unsubscribe.

No spam. Notifications only
aboutnew products and
updates. You can always
unsubscribe.