Quality Assurance Department

Focus on compliance

About the department

What do we do?

Owlpharma offers a comprehensive range of Quality Assurance services specifically designed for Marketing Authorization Holders (MAH), manufacturers, and wholesale distributors.

Why?

Integrated expertise that provides assurance of compliance with requirements worldwide.

QMS Support

  • GxP training;
  • QMS activities support (incl. SOP preparation and implementation);
  • Risk management design and execution.

End-to-End Projects

  • Supplier’s qualification & evaluation; 
  • EU Medical Device Regulation gap assessment; 
  • Annex 1 Contamination Control Strategy.

Inspection and Licensing Support

  • Liaison with health authorities;
  • Inspection preparation and support;
  • GxP | Medical Cannabis | Medical Devices.
Get to know our
Quality Assurance team
01

Medical & Scientific

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02

Quality Assurance

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03

Pharmacovigilance

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04

Audits

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05

More

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Beatriz Santos
Quality Assurance Junior Officer
Quality Assurance Department
André Luz
Quality Assurance Director
Quality Assurance Department
Lara Santos
Quality Assurance Officer
Quality Assurance Department
Gabriel Alves
Quality Assurance Associate Director
Quality Assurance 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

What we do in the M&S Department

01

Clinical

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

02

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.

03

Toxicology

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

2
2
M&S Team
Our Medical & Scientific team
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 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 Junior 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
Vanessa Branquinho
Regulatory Affairs Senior Officer
Regulatory Affairs Department
Beatriz Matias
Regulatory Affairs Senior Officer
Regulatory Affairs Department
Nuno Canoeiro
Regulatory Affairs Senior Officer
Regulatory Affairs Department
Isabel Rebelo
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
Joana Lucas
Administrative Assistant
Support
Diana Oliveira
Administrative Assistant
Support
Ana Margarida Andrade
Regulatory Affairs Director
Regulatory Affairs Department
Sara Oliveira
Medical & Scientific Senior Officer
Medical & Scientific Department
Ana Rita Félix
Medical & Scientific Senior Officer
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
Get to know our
Quality Assurance team
01

Medical & Scientific

Lorem ipsum dolor sit amet, consectetur adipiscing elit, sed do eiusmod tempor incididunt ut labore et dolore magna aliqua. Ut enim ad minim veniam, quis nostrud exercitation ullamco laboris nisi ut aliquip ex ea commodo consequat.

Learn more
02

Quality Assurance

Lorem ipsum dolor sit amet, consectetur adipiscing elit, sed do eiusmod tempor incididunt ut labore et dolore magna aliqua. Ut enim ad minim veniam, quis nostrud exercitation ullamco laboris nisi ut aliquip ex ea commodo consequat.

Learn more
03

Pharmacovigilance

Lorem ipsum dolor sit amet, consectetur adipiscing elit, sed do eiusmod tempor incididunt ut labore et dolore magna aliqua. Ut enim ad minim veniam, quis nostrud exercitation ullamco laboris nisi ut aliquip ex ea commodo consequat.

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04

Audits

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05

More

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Learn more
Meet our team
Beatriz Santos
Quality Assurance Junior Officer
Verónica Pinho
Medical & Scientific Junior Officer
Ana Rita Cordeiro
Pharmacovigilance Junior Officer
Daniela Vieira
Regulatory Affairs Junior Officer
Bruno Pedro
Medical Advisor
Helena Marques
REGULATORY AFFAIRS MANAGER
Érica Nunes
Pharmacovigilance Senior Officer
André Luz
Quality Assurance Director
Ricardo Andrade
Auditor PhV
César Gonçalves
Auditor GxP
Gabriel Alves
Auditor GxP
Cristina Serra
Auditor GxP
Lara Santos
Quality Assurance Officer
Gabriel Alves
Quality Assurance Associate Director
Bruno Pedro
Medical Advisor
Andreia Mónico
Medical & Scientific Manager
Lígia Ferreira
Medical & Scientific Director
Daniela Gomes
Pharmacovigilance Manager
Ricardo Andrade
EU QPPV
Mariana Rocha
Pharmacovigilance Director
Bárbara Macedo
Regulatory Affairs Senior Officer
Gina Abreu
Regulatory Affairs Junior Officer
Guilherme Monteiro
Regulatory Affairs Junior Officer
Adriana Alves
Regulatory Affairs Junior Officer
Dania Shriki
Regulatory Affairs Junior Officer
Libânia Alves
Regulatory Affairs Officer
Marta Almendra
Regulatory Affairs Officer
Elsa Morgado
Regulatory Affairs Officer
Polina Pastoukhova
Regulatory Affairs Officer
Inês Penedones
Regulatory Affairs Officer
Vanessa Branquinho
Regulatory Affairs Senior Officer
Beatriz Matias
Regulatory Affairs Senior Officer
Nuno Canoeiro
Regulatory Affairs Senior Officer
Isabel Rebelo
Regulatory Affairs Senior Officer
Rita Henriques
Regulatory Affairs Senior Officer
Alexandra Miranda
Regulatory Affairs Senior Officer
Rita Agrela
Regulatory Affairs Manager
Ana Teresa Martins
Regulatory Affairs Manager
Duarte Jesus
Regulatory Affairs Manager
Raquel Miguéis
Regulatory Affairs Associate Director
Frederico Nunes
Regulatory Affairs Associate Director
Mariana Pinto
Business Development Junior Officer
Eva Faria
Compliance Senior Officer
Andreia Ferreira
MEDICAL & SCIENtiFIC OFFICER
Joana Lucas
Administrative Assistant
Diana Oliveira
Administrative Assistant
Ana Margarida Andrade
Regulatory Affairs Director
Sara Oliveira
Medical & Scientific Senior Officer
Ana Rita Félix
Medical & Scientific Senior Officer
Margarida Tapadas
Quality Assurance Junior Officer
Carolina Pinto
Quality Assurance Junior Officer
José Rolim
Quality Assurance Officer
Catarina Mestre
Quality Assurance Officer
Marco Correia
Quality Assurance Senior Officer
Mariana Silva
Quality Assurance Manager
Inês Melo
Quality Assurance Senior Officer
Rafaela Schouten
Quality Assurance Manager
Ricardo Andrade
Managing Director
André Luz
Auditor GxP
César Gonçalves
Managing Director
José Gomes
Audits Director
Beatriz Viegas
Pharmacovigilance Junior Officer
Carolina Mesquita
Pharmacovigilance Junior Officer
Tânia Salvador
Pharmacovigilance Officer
Bruna Monteiro
Pharmacovigilance Officer
Sara França
Pharmacovigilance Manager
Sofia Antunes
Pharmacovigilance Manager
Ana Isabel Sousa
Pharmacovigilance Manager
Catarina Calado
Pharmacovigilance Senior Officer
Ana Cristina Silveiro
Pharmacovigilance Senior Officer
Rita Figueiredo
Pharmacovigilance Senior Officer
Ana Santos
Pharmacovigilance Officer
Sofia Santos
Pharmacovigilance Officer
Joana Fernandes
Pharmacovigilance Officer
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