The EU-funded CardioReGenix project focuses on technological innovations for the treatment of heart failure and myocardial ischemia. The goal is to overcome obstacles in cardiovascular disease (CVD) g...
Leer másAn international clinical trial is underway to evaluate on a large scale the effects of the first specific treatment for Polycystic Ovary Syndrome, a condition that affects between 5 and 10% of women ...
Leer másWe organized three great Webinars about veterinary regulation, ISO IDMP and DADI; AsphaWellbeing has been reshaped!; we launched a Regulatory Submissions ATLAS with the main regional eSubmissions requ...
Leer másOur team of experts have extensive experience with official local Spanish entities, such as the AEMPS, the Ministry of Health, local regional authorities and the College of Pharmacists association, am...
Leer másAt ASPHALION, we are proud to announce that we have been listed as “TOP PHARMACOVIGILANCE SOLUTIONS PROVIDER in EUROPE 2021” by Pharma Tech Outlook.
Leer másASPHALION is proud to be partner of this EU granted project, providing Regulatory Support throughout all stages of the project.
Leer másI am a medical device professional with R&D and regulatory background and over 10 years’ experience in the field of Medical Devices, combining a technical background with a fulfilling career in the ...
Leer másThe Global Pharmaceutical Regulatory Affairs Summit 2021 (GPRAS) will take place virtually from the 20th to the 22nd of April and Asphalion will be there!
Leer más The European Commission has launched a call, COVID19 – HERA Incubator (HORIZON-HLTH-2021-CORONA-01), that will mobilize all means and resources necessary to prevent, mitigate and respond to t...
Leer másAs of May 2022, IVDR will become fully applicable, displacing the old In vitro diagnostic directive (IVDD). Implementing IVDR will be much easier with a good action plan in place. Asphalion can aid yo...
Leer másOver the past weeks, several news on thromboembolic events potentially related to AstraZeneca’s vaccine for COVID-19 have been largely spread and disseminated.
Leer másThe upcoming application of the Medical Device Regulation (#MDR) on May 26th 2021 may signify your digital solution is subject of qualification as a Medical Device. Software as Medical Device (SaMD) m...
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