Resources Hub
Welcome to the Asphalion Resources Library
Resources Hub
Find here a collection of resources that can be useful in your day-to-day: Flyers, infographics, videos, webinars, whitepapers, etc.
We put at your disposal these useful and handy tools.
Regional Submissions Atlas
Flyers
A guide to have an overview of regional submissions requirements
Medical Devices Scientific and Regulatory Services
Flyers
Asphalion provides comprehensive support during development, certification and registration of Medical Devices in Europe, US as well as other selected regions.
Pharmacovigilance European Local Contact Network
Flyers
A network of qualified partners that allows ASPHALION to provide pharmacovigilance services throughout Europe
EUDAMED
Flyers
Asphalion provides dedicated services for all EUDAMED related activities with an
impact on manufacturers of medical devices
ATMPs
Flyers
Scientific & Regulatory Affairs Support during development of ATMPs & Biologics
Impact of MDR on directive 2001/83/EC
White Papers
All what you need to know about the impact of MDR on Directive 2001/83/EC.
EU Pharmacovigilance local contact services
Case Studies
EU Pharmacovigilance local contact services case study.
New study data update by FDA
Flyers
Beginning 15th September 2021
, FDA will enforce the
TechnicalRejection Criteria (TRC)
for Study Data by
CDER
and
CBER
.
CTIS training
Flyers
We are providing specific training for pharma and biotech companies inorder to guide them through the correct implementation of the new system.
Three Success Criteria for a Unified Regulatory Solution
White Papers
This white paper examines the business drivers behind this shift and three factors that are critical to maximizing thebenefits of a unified RIM solution.
Marketing Authorization Expansion in Europe
Case Studies
A case study about Marketing Authorization Expansion in Europe
Medical Device Software Development
White Papers
The EU Regulatory Environment of Medical Device Software Development
