Azierta Blog

Quality Audits are one of the main tools of the Quality Management System to check the status of compliance with the applicable regulations and propose the necessary ones corrective measures, despite the standard we are talking about (GMP, GLP, GCP, GDP, ISO 9001, ISO 13485, ISO 22716…), or the step of the product lifecycle (research […]

Marta Rodríguez Vélez | GXP Compliance & Safety Director | AZIERTA – July 2021   During the plenary session of the Spanish Parliament held on 10th June 2021 the constitution of the Health Subcommission was approved to study the regulation of the medicinal use of cannabis. This application is aimed at “analysing experiences of regulation […]

The Veterinary Medicinal Products Regulation (Regulation (EU) 2019/6) contains new legal provisions on veterinary pharmacovigilance. These aim to focus on continuous signal management based on adverse event data in the ‘Union Pharmacovigilance Database’ and cover pharmacovigilance inspections and the maintenance of pharmacovigilance master files. To assist marketing authorization holders in fulfilling their pharmacovigilance obligations, the […]

The science and health consultancy firm has supported the Catalonian pharmaceutical company in biosecurity areas Madrid, 11 May 2021 AZIERTA, a consultancy firm specialised in science and health, has completed a biosecurity project for the pharmaceutical company Reig Jofre, in order to ensure the biosecurity level necessary for handling the vaccine of the Belgium company Janssen Pharmaceutical, […]

The Alliance will jointly design and market advanced pharmacovigilance services both nationally and internationally. The Alliance will be a national leader in the sector in the provision of comprehensive pharmacovigilance services and a European benchmark. Madrid, April 2020. AZIERTA, a global science and health consulting firm specialized in accompanying the healthcare industry in its scientific […]

Following Brexit and in order to avoid stock-outs in the UK, the MHRA has made exceptional procedures. – European Commission (EC) Decision Reliance Procedure: For a period of two years from 1 January 2021, when determining an application for a Great Britain Marketing Authorisations (MA), the MHRA may rely on a decision taken by the […]

Market surveillance and control are a fundamental part of the marketing of both medical devices and cosmetics, sectors in continuous innovation and of great importance in the European and Spanish market. Medical devices are an essential sector for the provision of healthcare and therefore require a high level of health protection for patients and users. […]

The relationship between Health and The Economy Health before The Economy? The Economy before Health? Both at the same time? In short, I’m not going to demonise anyone or indulge in demagoguery.  You need money to buy food, you need food for good health. So, if you are healthy, you can earn money and you can […]

AZIERTA launched its new DS&G unit in an online event organised for the top management representatives of companies from the Healthcare Sector. In this webinar, Dr Antonio Borregón, the leader of the new DS&G unit and Chief Digital Officer, who was accompanied by Marta Rodríguez, Health Industry Director, shared the key points of the Business 2.0 Model for […]

What steps should be taken to grow cannabis for medicinal use in Spain? And for the manufacture of active substances derived from cannabis? Can I grow cannabis in Spain and sell it to my customer in Germany? What do I need? These and other questions are common among companies who want to start their business in the […]