EU MDR deadline officially postponed to 2021
Taking into consideration the importance of the continuous availability of those Medical Devices such as intensive care ventilators, surgical masks, medical gloves, etc. that are crucially important for public health in the context of the COVID-19 outbreak, the European Council and Parliament have officially adopted an amendment to Regulation 2017/745, postponing the application date of EU MDR to May 2021.
Compliance with 2020 GMP Annex 1
The second draft of GMP Annex 1 has been recently released and the issue date for the new revision is finally approaching. The document, a milestone standard for all sterile manufacturers, has been widely revised and extended, with important insights and implementations for the sterility assurance of the finished products. Discover the new challenges for sterile manufacturers.
Free on-demand Webinars
In this critical time, PQE Group takes the responsibility of applying a proactive approach to spread knowledge and give business insights on the most relevant topic in the Life Science industry without the need to travel.
While working remotely, get free access to the recordings of engaging online seminars, available in different languages and led by our experts.
Together we make a better world
We at PQE Group strongly believe that our success is deeply tied to the well-being of the community and the environment in which we live. Therefore, as a corporate, we feel the responsibility to foster the change we wish to see in the World, as Ghandi said.
Discover our main driver and inspiration for taking into action social awareness, environmental sustainability, equality and community empowerment.
On September 26th, 2019 the CMDh published the notice “Information on nitrosamines for marketing authorisation holders” asking to all Marketing Authorization Holders (MAHs) of human medicinal products containing chemically synthesised active pharmaceutical ingredients to evaluate the risk of the presence of nitrosamine impurities in their products. This includes generics and over-the counter (OTC) products.
PQE Group is taking the COVID-19 diffusion really seriously: health and safety dispositions have been applied in all PQE Group offices worldwide to prevent the diffusion of the virus. Our services and resources are granted on all projects and safe from Coronavirus.
Projects in critical geopolitical context are guaranteed by our solid Front-End/Back-End Service Model.
PQE Group supports Life Science companies from the Pharmaceutical and the Medical Device industries in every phase of the product lifecycle, offering tailored Quality Solutions deliverable by our specialized team in your language.
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Although we at PQE believe in taking actions and not in numbers, we think that the secret to a successful consulting company lies between its people, environment and know-how. These are the features we are most proud of.
A full support for Life Science
In its 20+ years of life, PQE has worked with thousands of clients and always applied the latest technologies and discoveries to help companies achieving their full potential. As an innovation-based agency, we are constantly developing new services and updating our areas of expertise.
Discover the fields we are proficient in.
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