AZIERTA celebrates the launch of Digital, Science & Growth,...
AZIERTA celebrates the launch of Digital, Science & Growth, its Digital Transformation Consultancy Unit
Events and news
BlogDigital, Science & Growth
December 28, 2020
AZIERTA celebrates the launch of Digital, Science & Growth, its Digital Transformation Consultancy Unit
Toxicology
December 15, 2020
What do you need for the cultivation of medicinal cannabis in Europe?
Toxicology
December 4, 2020
Azierta Webinar on the new requirements for Safety Data Sheets that will come into force on 1 January 2021
Azierta
November 12, 2020
Azierta launches Digital, Science & Growth (DS&G), its new business unit dedicated to the digital transformation of companies...
Quality
October 29, 2020
Last September, ECA offered the first Cleaning Validation Online Training Course. After the session, participants had the...
Toxicology
October 28, 2020
The webinar discussed the essential aspects of nitrosamines impurities, which can be carcinogenic and require manufacturers...
Azierta
September 22, 2020
The Alliance will design a joint offer at a consulting level for the design of installations in pharmaceutical plants, participating...
Pharmacovigilance
September 3, 2020
On September 1st, the Medicines and Healthcare products Regulatory Agency (MHRA) published a pharmacovigilance update for...
Azierta
June 16, 2020
The Alliance will be a leader in the Healthcare Consulting sector in this area.
Azierta
April 22, 2020
The consultancy firm AZIERTA provides Spanish and European researchers with its resources to promote the fight against the...
Regulatory Affairs
April 22, 2020
Although numerous clinical trials are underway, there is currently no evidence from controlled clinical trials to recommend...
Toxicology
January 15, 2020
In the last few years, elastomer, thermoplastic or thermostable plastic polymeric materials have become established as basic...
Azierta
January 15, 2020
Pharmaceutical companies are faced with the need to outsource the manufacturing processes of their products for a variety...
Azierta
January 15, 2020
At Azierta, we are experts in developing turnkey projects to optimize time and resources to capitalize on European business...
Toxicology
December 9, 2019
ICHQ3D implementation involves a risk analysis to design strategies to control elemental impurities in drugs for human use,...
Toxicology
December 9, 2019
ICH Q3D Guideline is focused to limit the presence of potentially toxic elemental impurities in the human medicines. Deadline...
Toxicology
December 9, 2019
The implementation of ICH Q3D has already become in a reality, and the requirements and implementation dates represent a...
Regulatory Affairs
December 9, 2019
Positioned as the second largest pharmaceutical market in the world and showing a steady and extensive growth pattern, Europe’s...
Regulatory Affairs
November 27, 2019
What are Advanced Therapies? Advanced-therapy medicines are medicines that are made from genes and cells. They may offer...
Medical Devices
November 27, 2019
The European Commission has finally adopted in August 2017 the DECISION (EU) 2017/1445 on the qualification of cranberry...
Toxicology
November 27, 2019
ICH Q3D Guideline is focused to limit the presence of potentially toxic elemental impurities in human medicines. But there...
Toxicology
November 27, 2019
Chemical substances are being increasingly used in different sectors, including the pharmaceutical one. Thousands of these...
Pharmacovigilance
November 27, 2019
According to ICH guideline E2F (Step 5) on Development Safety Update Reports (DSURs) already implemented since 2011, companies...
Pharmacovigilance
November 27, 2019
In September 2010, the International Conference Harmonisation developed the ICH E2F Guideline for the Development Safety...
Regulatory Affairs
November 27, 2019
In recent years, the volume of generic drug sales has been increasing rapidly in Europe, whereas the outsourcing of branded...
Toxicology
November 27, 2019
The packaging materials for pharmaceutical products are designed to protect them from environmental contamination. However,...
Pharmacovigilance
November 27, 2019
According to European Medicaments Agency (EMA) guidelines, already implemented since 2012; Marketing Authorization Holders...
Regulatory Affairs
November 27, 2019
The action plan developed by the AEMPS and published April 2016 focuses on the set up of specific activities, such as the...
Toxicology
November 27, 2019
The environmental risk assessment process for a medicinal product is complex. It is based on overall usage, destination...
Toxicology
November 27, 2019
The aim of the hazard assessment is to determine the classification and labelling of the substance and to establish the...
Toxicology
November 27, 2019
The range of polymeric materials available in the industry is very broad and materials have been developed with very different...
Toxicology
November 27, 2019
Identification and quantification of impurities in active ingredients and drugs products is a crucial aspect in pharmaceutical...
Medical Devices
November 26, 2019
Since 2012 the European Union (EU) has been working on the improvement and modernizing of the EU rules on medical devices...
Pharmacovigilance
November 26, 2019
European Medicines Agency published Module V of Good Vigilance Practices in 2012 and it was later revised in April 2014....
Toxicology
November 26, 2019
When assessing pharmacological and toxicological profile of chemical structures, several approaches are possible, including...
Toxicology
November 26, 2019
Azierta
November 26, 2019
Large, diversified and global, the Pharmaceutical Industry is one of the most competitive sectors in the European economy....
Toxicology
November 25, 2019
On June 2016 will be coming into effect for veterinary medicaments EMA’s guideline (EMA/CHMP/CVMP/SWP/169430/2012) already...
Toxicology
November 25, 2019
After the banding control has been established along with the strategies to be followed, it is necessary to carry out a...
Pharmacovigilance
November 21, 2019
The European pharmacovigilance legislation requires marketing authorization holders (hereinafter MAHs) to continuously monitor...
Toxicology
November 21, 2019
The loss of quality of the medication due to the presence of extractables and leachables added to the risk that these impurities...
Pharmacovigilance
November 21, 2019
Las Buenas Prácticas de Farmacovigilancia (Good Pharmacovigillance Practices – GVP) publicadas por la EMA constituyen la...
Pharmacovigilance
November 21, 2019
In early 2016, the European Medicines Agency (EMA) started a major revision process of the good pharmacovigilance practice...
Toxicology
November 21, 2019
Depending on their chemical nature and migratory properties from the container to the medium, these types of organic or...
Regulatory Affairs
November 21, 2019
The European pharma market is becoming more competitive and accessible through its effort to adopt globally acknowledged...
Toxicology
November 21, 2019
Solvents used in pharmaceutical industry are generally volatile organic compounds that are involved in many processes of...
Pharmacovigilance
November 21, 2019
At the end of 2017, a new version of Eudravigilance went online to manage suspected adverse reactions to medicines. This...
Regulatory Affairs
November 20, 2019
On 29 March 2017, the United Kingdom notified the European Council of its intention to withdraw from the European Union,...
Toxicology
November 20, 2019
Mutagenic impurities assessment following ICH M7 guideline comprises impurities identification and classification, followed...
Pharmacovigilance
November 20, 2019
On 31 March 2017, the EMA released a second revision of Module V- Risk Management Systems of Good Pharmacovigilance Practice...
Toxicology
November 19, 2019
After calculating the OEL and categorising the substance, the Occupational Exposure Band (OEB) must be obtained that will...
Toxicology
November 12, 2019
Use of pesticides is a key factor in control agricultural and food pests and to pest vector control, especially in epidemics....
Azierta
November 11, 2019
The Pharmaceutical Market in EU has a value of over 183 Million €, positioning Europe as the second biggest pharmaceutical...
Toxicology
November 11, 2019
Directive ICH Q3D aims to limit the presence of potentially toxic elemental impurities (also known as heavy metals) in pharmaceutical...
Toxicology
November 11, 2019
Our experience with the implementation of ICH Q3D has showed that the new approach is not always well-understood by suppliers,...
Pharmacovigilance
November 11, 2019
The addendum to the clinical overview collects all cumulated effectiveness and safety data related to a medicinal product...
Toxicology
November 11, 2019
Any component present in an active ingredient or in a finished product which is neither the active ingredient nor an excipient...
Azierta
October 7, 2019
Cambridge, Massachusetts and Madrid, Spain – Paredox Therapeutics, LLC, Azierta Contract Scientific Support Consulting,...
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