Have a look at this timeline that Asphalion experts have prepared for you to take into consideration about the regulatory requirements for Data Disclosure. You can also discover Asphalion’s expertise on EMA Policy 0070 Policy, EMA Policy 0043, CTIS, etc., linked to EMA requirements.
Have a look at the document here: Data Disclosure Regulatory Requirements
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At ASPHALION we are pleased to announce our participation in RAPS EuroConvergence 2025, one of the premier regulatory affairs events in Europe. This year’s conference
Join us for an in-depth session abput “Biological Impurities: Scientific and Regulatory Aspects”, where our Regulatory Affairs expert Mario López de la Cruz will guide
On April 24, 2025, the Committee for Medicinal Products for Human Use (CHMP) adopted the draft ICH Q1 Guideline on Stability Testing of Drug Substances
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