27 Mar 2020 OFF-SITE AUDITS

26 Mar 2020

NITROSAMINES – RISK EVALUATION EXTENDED TO OCTOBER 2020

EMA has published an update on their website extending the completion date for the risk assessment of nitrosamines – step 1. The new submission deadline is the 1st of October 2020, more information is expected to be published tomorrow.

16 Mar 2020

COVID-19 - Business Continuity Plan Activation

Following recent developments and immediately after WHO announcement of COVID-19 virus outbreak classification as a pandemic, OWLPHARMA has decided to activate its business continuity plan.

21 Feb 2020

Safety Assessment of Cosmetic Products

Regulation (EC) no. 1223/2009 stipulates that all cosmetic products, prior to being marketed in the EU, must undergo a safety assessment carried out by a qualified person. The assessment must always be kept up to date, and any relevant information generated after the product is placed on the market has to be taken into account.

18 Feb 2020

Regulatory Day 2020

6 Feb 2020

Estamos a recrutar - Medical Writer

A OWLpharma tem em aberto uma vaga para Medical Writer no Departamento Médico-Científico, em Coimbra.

21 Jan 2020

Nitrosamines – Risk evaluation

At the end of September EMA began a review under the Article 5(3) of Regulation (EC) No 726/2004 to provide guidance for MAHs on how to avoid nitrosamines in human medicines.