News & Events
Let´s Meet! | Schedule Your Expert Consultation Seamlessly!
Harness the power of convenience with Asphalion’s scheduling tool – a streamlined way to arrange a meeting with our Regulatory and Safety experts.
WEBINAR RECORDING | ISO IDMP key updates
Watch Asphalion expert Beatriz Ugalde, Regulatory Data Manager, delve into the key updates of the ISO IDMP
EVENT | PMS Info-day
Specially aimed at representatives from human trade organizations and national competent authorities
NEWS | ICH Q14 Guideline on analytical procedure development
This guideline describes science and risk-based approaches for developing and maintaining analytical procedures suitable for the evaluation of the quality of drug substances and drug products. It complements ICH Q2 Validation of Analytical Procedures.
WEBINAR RECORDING | Review of hot topics in Regulatory & Safety + Outlook into 2024
Watch Asphalion experts Carlos Domingo Palacios, Beatriz Ugalde, Adi Ickowicz, Rosa Sellabona, Álvaro Villarino, Vanesa Palau González,
ASPHALION | MAGIC LINE 2024
Our team from Barcelona took part in the Magic Line 2024 last sunday, walking for 21 Km.
NEWS | QWP Questions and Answers: how to use a CEP in the context of a Marketing Authorisation Application (MAA) or a Marketing Authorisation Variation (MAV)
This document aims to clarify existing guidance as a compilation of required data to be submitted in a MAA or in certain MAVs when a CEP is referred to in the MA dossier. It is also applicable when an excipient covered by a CEP is used as an active substance (AS). Even if several aspects of this document would equally apply to ASMFs and when full information on active substance is provided in the MA dossier, the focus of this Q&A is on CEPs.
HORIZON | ETERNAL 18-month progress meeting
The EU-funded project ETERNAL partners gathered in Rome this week to discuss the ongoing progress of the
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