Regulatory Affairs Department

Full-spectrum support

About the department

What do we do?

Full regulatory support from the initial guidance to dossier preparation/build-up, MA submission and post-MA dossier management, for both national and international markets.

Why?

To help companies streamline the regulatory process, minimize delays, and increase the likelihood of successful regulatory outcomes.

Development

  • Review and preparation of MA dossiers;
  • Definition of regulatory strategies for MA approval; 
  • Conversion to eCTD format.

Pre-MA

  • Preparation, submission and management of MA applications (EU and non-EU);
  • Local representative as MAHs;
  • Price and reimbursement applications;
  • Regulatory support on the launch and marketing of medicines.

Post-MA

  • Preparation, submission and management of variation and renewal applications of MA (EU and non-EU);
  • Drug information management on Eudravigilance Platform (XEVMPD);
  • Advertising regulatory support.
Get to know our
Regulatory Affairs 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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Sarah Matos
Regulatory Affairs Junior Officer
Regulatory Affairs Department
Eduarda Soares
Regulatory Affairs Junior Officer
Regulatory Affairs Department
Margarida Ribeiro
Regulatory Affairs Junior Officer
Regulatory Affairs Department
Inês Silva
Regulatory Affairs Junior Officer
Regulatory Affairs Department
Diana Mendes
Regulatory Affairs Junior Officer
Regulatory Affairs Department
Bernardo Gameiro
Regulatory Affairs Junior Officer
Regulatory Affairs Department
Helena Marques
REGULATORY AFFAIRS SENIOR MANAGER
Regulatory Affairs Department
Bárbara Macedo
Regulatory Affairs Manager
Regulatory Affairs Department
Gina Abreu
Regulatory Affairs Junior Officer
Regulatory Affairs Department
Guilherme Monteiro
Regulatory Affairs Officer
Regulatory Affairs Department
Adriana Alves
Regulatory Affairs 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
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
Ana Margarida Andrade
Regulatory Affairs Director
Regulatory Affairs 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
Ana Nogueira
Quality Assurance Officer
Quality Assurance Department
Sarah Matos
Regulatory Affairs Junior Officer
Regulatory Affairs Department
Céline Gil
Pharmacovigilance Junior Officer
Pharmacovigilance Department
Eduarda Soares
Regulatory Affairs Junior Officer
Regulatory Affairs Department
Ana Catarina Correia
Medical & Scientific Junior Officer
Medical & Scientific Department
Margarida Ribeiro
Regulatory Affairs Junior Officer
Regulatory Affairs Department
Inês Silva
Regulatory Affairs Junior Officer
Regulatory Affairs Department
Diana Mendes
Regulatory Affairs Junior Officer
Regulatory Affairs Department
Bernardo Gameiro
Regulatory Affairs Junior Officer
Regulatory Affairs Department
Francisca Ataíde
Quality Assurance Junior Officer
Quality Assurance Department
Matilde Pina
Auditor GXP
Audits 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 Senior Officer
Quality Assurance Department
Gustavo Sousa
Auditor GxP
Audits Department
Verónica Pinho
Medical & Scientific Officer
Medical & Scientific Department
Ana Rita Cordeiro
Pharmacovigilance Junior Officer
Pharmacovigilance 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
Auditor GxP
Audits Department
Gabriel Alves
Quality Assurance Associate Director
Quality Assurance Department
Bruno Pedro
Medical Advisor
Medical & Scientific Department
Andreia Mónico
Medical & Scientific Senior 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 Manager
Regulatory Affairs Department
Gina Abreu
Regulatory Affairs Junior Officer
Regulatory Affairs Department
Guilherme Monteiro
Regulatory Affairs Officer
Regulatory Affairs Department
Adriana Alves
Regulatory Affairs 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
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 Officer
Support
Eva Faria
Compliance Senior Officer
Support
Andreia Ferreira
MEDICAL & SCIENtiFIC 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 Officer
Quality Assurance Department
Carolina Pinto
Quality Assurance Officer
Quality Assurance Department
José Rolim
Quality Assurance Officer
Quality Assurance Department
Catarina Mestre
Quality Assurance Officer
Quality Assurance Department
Mariana Silva
Quality Assurance Manager
Quality Assurance Department
Inês Melo
Quality Assurance Senior Officer
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 Officer
Pharmacovigilance Department
Bruna Monteiro
Pharmacovigilance Officer
Pharmacovigilance Department
Sara França
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 Senior Officer
Pharmacovigilance Department
Sofia Santos
Pharmacovigilance Officer
Pharmacovigilance Department
Joana Fernandes
Pharmacovigilance Officer
Pharmacovigilance Department
Get to know our
Regulatory Affairs 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.

Learn more
04

Audits

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
05

More

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Learn more
Meet our team
Ana Nogueira
Quality Assurance Officer
Sarah Matos
Regulatory Affairs Junior Officer
Céline Gil
Pharmacovigilance Junior Officer
Eduarda Soares
Regulatory Affairs Junior Officer
Ana Catarina Correia
Medical & Scientific Junior Officer
Margarida Ribeiro
Regulatory Affairs Junior Officer
Inês Silva
Regulatory Affairs Junior Officer
Diana Mendes
Regulatory Affairs Junior Officer
Bernardo Gameiro
Regulatory Affairs Junior Officer
Francisca Ataíde
Quality Assurance Junior Officer
Matilde Pina
Auditor GXP
Juliana Salvado
Pharmacovigilance Junior Officer
Tatiana Graça
ADMINISTRATIVE JUNIOR OFFICER
Mariana Oliveira
Pharmacovigilance Junior Officer
Nathália Santana
Quality Assurance Senior Officer
Gustavo Sousa
Auditor GxP
Verónica Pinho
Medical & Scientific Officer
Ana Rita Cordeiro
Pharmacovigilance Junior Officer
Bruno Pedro
Medical Advisor
Helena Marques
REGULATORY AFFAIRS SENIOR 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
Auditor GxP
Gabriel Alves
Quality Assurance Associate Director
Bruno Pedro
Medical Advisor
Andreia Mónico
Medical & Scientific Senior Manager
Lígia Ferreira
Medical & Scientific Director
Daniela Gomes
Pharmacovigilance Manager
Ricardo Andrade
EU QPPV
Mariana Rocha
Pharmacovigilance Director
Bárbara Macedo
Regulatory Affairs Manager
Gina Abreu
Regulatory Affairs Junior Officer
Guilherme Monteiro
Regulatory Affairs Officer
Adriana Alves
Regulatory Affairs Officer
Dania Shriki
Regulatory Affairs 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
Beatriz Matias
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 Officer
Eva Faria
Compliance Senior Officer
Andreia Ferreira
MEDICAL & SCIENtiFIC OFFICER
Diana Oliveira
Administrative Senior Manager
Ana Margarida Andrade
Regulatory Affairs Director
Sara Oliveira
Medical & Scientific Manager
Ana Rita Félix
Medical & Scientific Manager
Margarida Tapadas
Quality Assurance Officer
Carolina Pinto
Quality Assurance Officer
José Rolim
Quality Assurance Officer
Catarina Mestre
Quality Assurance Officer
Mariana Silva
Quality Assurance Manager
Inês Melo
Quality Assurance Senior Officer
Ricardo Andrade
Managing Director
André Luz
Auditor GxP
César Gonçalves
Managing Director
José Gomes
Audits Director
Beatriz Viegas
Pharmacovigilance Officer
Carolina Mesquita
Pharmacovigilance Officer
Tânia Salvador
Pharmacovigilance Officer
Bruna Monteiro
Pharmacovigilance Officer
Sara França
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 Senior Officer
Sofia Santos
Pharmacovigilance Officer
Joana Fernandes
Pharmacovigilance Officer
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