Asphalion offers a full range of services to provide a comprehensive support for data compliance for:
Being a reference point for xEVMPD services, we are fully ready to support companies with:
Asphalion offers a full range of services to provide a comprehensive support for data compliance for:
Being a reference point for xEVMPD services, we are fully ready to support companies with:
Regulatory Operations: Data Management Solutions
At Asphalion we can give you support and help you navigate through the awareness process and work with you to be ISO IDMP compliant whether you have, need or can’t yet access a RIM system.
Importance of 3rd Acknowledgement management in the context of data migration to PMS
⚠️ Managing EMA’s 3rd ACK is a crucial step in the context of migrating xEVMPD data into PMS, aimed at preventing and minimizing inconsistent data input into both the PMS database and eAF.
If you need further information or wish to explore how we can assist you during this transition:
If you need further information or wish to explore how we can assist you during this transition:
If you need further information or wish to explore how we can assist you during this transition:
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Why Asphalion?
xEVMPD Compliance
RIMS Implementation Expertise
Leading ISO IDMP Transition
Related Resources
DADI Webinar: Are you ready for Go-Live?
Regulatory Landscape in the UK: an update – Asphalion Webinar
RIM Implementation in times of IDMP – Asphalion Webinar
How to set-up your Post-Market Surveillance and Vigilance system for IVDs according to IVDR – Asphalion Webinar
Efficient IDMP implementation in different sized pharma companies: practical experience and FAQs – Asphalion Webinar
EUDAMED Module 2 Webinar with Lídia Cánovas and Francisco Rogríguez (Asphalion)
Asphalion provides dedicated services for all EUDAMED related activities with an
impact on manufacturers of medical devices
Beginning 15th September 2021
, FDA will enforce the
TechnicalRejection Criteria (TRC)
for Study Data by
CDER
and
CBER
.
A whitepaper about how to select your perfect RIMS
This white paper examines the business drivers behind this shift and three factors that are critical to maximizing thebenefits of a unified RIM solution.
The EU Regulatory Environment of Medical Device Software Development
EMA is holding a new public event with the purpose to provide a comprehensive understanding of Product Management Service (PMS) and its implications on other EMA digital services with the objective to introduce the core concepts of PMS, ensuring that all attendees have the chance to understand its implementation.
EMA held the first system demo of 2024, the ninth ever held by them as part of its Agile Network Portfolio management.
Harness the power of convenience with Asphalion’s scheduling tool – a streamlined way to arrange a meeting with our Regulatory and Safety experts.
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