It is with great pleasure and enthusiasm that we would like to inform you about the implementation of SAP, our new Enterprise Resource Planning (ERP) system.
Read moreOne of the first steps executed by the EMA to prepare for the implementation of ISO IDMP will be the migration into the new PMS database.
Read moreNow that the year is about to come to an end, the European Commission has updated the information on the MDCG’s work in progress, indicating the planning for the endorsement of the guidance document...
Read moreBy adopting the Digital Healthcare Act (DVG) (October 5th, 2019), Germany became a pioneer in Healthcare App insured prescription, marking one of the greatest milestones for the Medical Device Softwar...
Read moreNext month, Dominique Monferrer will hold a webinar aimed to help manufacturers of in vitro diagnostic medical devices to understand the impact of the new In Vitro Diagnostic Regulation (IVDR), the mo...
Read moreBIO-Europe® Digital 2020, the largest life science partnering event worldwide, will take place next week, October 26th-29th. This event will be held digitally and Asphalion will be there!
Read moreAsphalion has signed an agreement to be part of Barcelona Health Hub (BHH), the international digital health institution aiming to promote innovation in digital health and its transfer to the se...
Read moreThe Advanced FDA Regulatory Affairs online training course will take place on the 4th and 5th of November, 2020 and it will provide you with an insight into the required information on how to set up y...
Read moreIn both 2018 and 2019 the presence of N-nitrosamines was found in sartans with a tetrazole ring but it was also detected in other API/medicinal products (e.g. in some batches of pioglitazone and ranit...
Read moreFrom 1 January 2021, the Medicines and Healthcare products Regulatory Agency (MHRA) will be the UK’s standalone medicines and medical devices regulator.
Read moreThe European Commission has launched a Manifesto to maximise the accessibility of research results in the fight against COVID-19 and Asphalion has signed it to reinforce its commitment to bring soluti...
Read moreFrom 19 October 2020, scientific advice applicants will be required to use the IRIS Platform for Regulatory and Scientific Information Management to manage the scientific advice processes with EMA. To...
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