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.
MA Dossiers Audits

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

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

Medical & Scientific

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Quality Assurance

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Pharmacovigilance

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Audits

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Meet our team

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Regulatory Affairs Department

Full-spectrum support

About the department

What do we do?

Why?

Development

Pre-MA

Post-MA

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

Contact us

About

Drivers

Partnerships

Locations

Medical & Scientific

Quality Assurance

Regulatory Affairs

Pharmacovigilance

Audits

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