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).

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

Inês Graça

Quality Assurance Junior Officer

Quality Assurance Department

Bernardo Ferreira

Pharmacovigilance Junior Officer

Pharmacovigilance Department

Telmo Lagoa

Regulatory Affairs Junior Officer

Regulatory Affairs Department

Ana Cristina Oliveira

Administrative Assistant

Support

Márcia Azevedo

Medical & Scientific Junior Officer

Medical & Scientific Department

Carolina Azevedo

Quality Assurance Junior Officer

Quality Assurance Department

Raquel Fernando

Medical & Scientific Officer

Medical & Scientific Department

Verónica Pinho

Medical & Scientific Senior Officer

Medical Devices Department

Bruna Monteiro

Vigilance Senior Officer

Medical Devices Department

Alexandra Miranda

Regulatory Affairs Manager

Medical Devices Department

Frederico Nunes

Medical Devices Director

Medical Devices Department

Mariana Silva

Quality Assurance Manager

Medical Devices Department

Gonçalo Pascoal

Quality Assurance Junior Officer

Quality Assurance Department

Maryna Danylyuk

Quality Assurance Officer

Quality Assurance Department

Mateus Marques

Auditor GxP

Audits Department

Pedro Rodrigues

Auditor GxP

Audits Department

Mariana Borralho

Quality Assurance Officer

Quality Assurance Department

Mariana Ambrósio

Human Resources Manager

Support

Beatriz Neves

Regulatory Affairs Junior Officer

Regulatory Affairs Department

Cátia Saraiva

Regulatory Affairs Officer

Regulatory Affairs Department

Ana Rita Gomes

Medical & Scientific Officer

Medical & Scientific Department

Tânia Lopes

Compliance Officer

Support

Rita Montanha

Quality Assurance Junior Officer

Quality Assurance Department

Inês Coelho

Pharmacovigilance Junior Officer

Pharmacovigilance Department

Daniela Madeira

Pharmacovigilance Officer

Pharmacovigilance Department

Ana Pacheco

Compliance Junior Officer

Support

Matilde Rodrigues

Medical & Scientific Officer

Medical & Scientific Department

Margarida Corte-Real

Pharmacovigilance Officer

Pharmacovigilance Department

Maria Rocha

Pharmacovigilance Officer

Pharmacovigilance Department

Carolina Dias

Pharmacovigilance Officer

Pharmacovigilance Department

Beatriz Navega

Pharmacovigilance Officer

Pharmacovigilance Department

Daniela Gomes

Auditor PhV

Audits Department

Ana Nogueira

Quality Assurance Senior Officer

Quality Assurance Department

Sarah Matos

Regulatory Affairs Officer

Regulatory Affairs Department

Céline Gil

Pharmacovigilance Officer

Pharmacovigilance Department

Eduarda Soares

Regulatory Affairs Officer

Regulatory Affairs Department

Ana Catarina Correia

Medical & Scientific Officer

Medical & Scientific Department

Margarida Ribeiro

Regulatory Affairs Officer

Regulatory Affairs Department

Inês Silva

Regulatory Affairs Officer

Regulatory Affairs Department

Diana Mendes

Regulatory Affairs Officer

Regulatory Affairs Department

Bernardo Gameiro

Regulatory Affairs Officer

Regulatory Affairs Department

Francisca Ataíde

Quality Assurance Officer

Quality Assurance Department

Matilde Pina

Auditor GXP

Audits Department

Juliana Salvado

Pharmacovigilance Officer

Pharmacovigilance Department

Mariana Oliveira

Pharmacovigilance Officer

Pharmacovigilance Department

Nathália Santana

Quality Assurance Officer

Quality Assurance Department

Gustavo Sousa

Auditor GxP

Audits Department

Verónica Pinho

Medical & Scientific Senior Officer

Medical & Scientific Department

Ana Rita Cordeiro

Pharmacovigilance Senior Officer

Pharmacovigilance Department

Bruno Pedro

Medical Advisor

Pharmacovigilance Department

Helena Marques

Regulatory Affairs Senior Officer

Regulatory Affairs Department

Érica Nunes

Pharmacovigilance Senior Officer

Pharmacovigilance Department

André Luz

Managing Director

Managers

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

Auditor GxP

Audits Department

Gabriel Alves

Quality Assurance Director

Quality Assurance Department

Bruno Pedro

Medical Advisor

Medical & Scientific Department

Andreia Mónico

Medical & Scientific Associate Director

Medical & Scientific Department

Lígia Ferreira

Medical & Scientific Director

Medical & Scientific Department

Daniela Gomes

Pharmacovigilance Associate Director

Pharmacovigilance Department

Ricardo Andrade

EU QPPV

Pharmacovigilance Department

Mariana Rocha

Pharmacovigilance Director

Pharmacovigilance Department

Bárbara Macedo

Regulatory Affairs Manager

Regulatory Affairs Department

Gina Abreu

Regulatory Affairs Officer

Regulatory Affairs Department

Guilherme Monteiro

Regulatory Affairs Officer

Regulatory Affairs Department

Adriana Alves

Regulatory Affairs Officer

Regulatory Affairs Department

Dania Shriki

Regulatory Affairs Senior Officer

Regulatory Affairs Department

Libânia Alves

Regulatory Affairs Senior Officer

Regulatory Affairs Department

Marta Almendra

Regulatory Affairs Senior Officer

Regulatory Affairs Department

Elsa Morgado

Regulatory Affairs Senior Officer

Regulatory Affairs Department

Polina Pastoukhova

Regulatory Affairs Officer

Regulatory Affairs Department

Inês Penedones

Regulatory Affairs Manager

Regulatory Affairs Department

Beatriz Matias

Regulatory Affairs Senior Officer

Regulatory Affairs Department

Alexandra Miranda

Regulatory Affairs Manager

Regulatory Affairs Department

Rita Agrela

Regulatory Affairs Senior Manager

Regulatory Affairs Department

Ana Teresa Martins

Regulatory Affairs Manager

Regulatory Affairs Department

Duarte Jesus

Regulatory Affairs Associate Director

Regulatory Affairs Department

Raquel Miguéis

Regulatory Affairs Associate Director

Regulatory Affairs Department

Mariana Pinto

Business Development Manager

Support

Eva Faria

Compliance Manager

Support

Andreia Ferreira

Medical & Scientific Senior Officer

Medical & Scientific Department

Diana Oliveira

Administrative Senior 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 Senior Officer

Quality Assurance Department

Carolina Pinto

Quality Assurance Officer

Quality Assurance Department

José Rolim

Quality Assurance Senior Officer

Quality Assurance Department

Mariana Silva

Quality Assurance Manager

Quality Assurance Department

Inês Melo

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 Officer

Pharmacovigilance Department

Carolina Mesquita

Pharmacovigilance Officer

Pharmacovigilance Department

Tânia Salvador

Pharmacovigilance Senior 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?

Why?

Pharmacovigilance Audits

GMDP Audits

GCP 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.