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office@crofar.com
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Regulatory Affairs

Advisory and consultancy scientific and regulatory

Human Medicines

Preparation of dossiers for (national) submission of marketing-authorisation applications (MAA), including PIL readability tests, PIL…

Cosmetics

Advice in Portuguese and European regulatory requirements;Preparation, maintenance and update of Product Information File (PIF),…

Food supplements

Advice in Portuguese and European regulatory requirements;Verification of Nutrition and Health Claims;Advice/revision of packaging materials,…

Veterinary Medicines

Submission of Market Authorization applications/variations.

Pharmacovigilance

Local Qualified Person for PV in Portugal on behalf of Market Authorization Holders;Local contact (Local…

Medical Devices

Regulatory and scientific advice of medical devices;Registration of MD/IVD (on behalf of its manufacturers/authorized representatives)…

The new Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDMD)

September 3, 2020

The new Regulation (EU) 2017/746 will significantly change the regulatory requirements on IVDMD (mainly represented by the European Directive 98/79/EC…

Normas para Atribuição do Título de Especialista em Farmácia Comunitária

July 15, 2020

Regulamento n.º 567/2020 Publicação: Diário da República n.º 134/2020, Série II de 2020-07-13 Emissor: Ordem dos Farmacêuticos Disponível em: https://dre.pt/web/guest/pesquisa/-/search/137615373/details/maximized

EMA finalises opinion on presence of nitrosamines in medicines

July 15, 2020

EMA’s human medicines committee (CHMP) has issued an opinion requiring companies to take measures to limit the presence of nitrosamines…