Resources Hub
Welcome to the Asphalion Resources Repository
Global Pharmaceutical
Regulatory Agencies Directory
Interactive directory of the main pharmaceutical regulatory agencies around the world.
Asphalion
MedTech Blog
A compilation of insightful articles on MedTech Regulatory Affairs
Glossary of Pharmaceutical
Regulatory Acronyms
Comprehensive glossary that provides clear definitions of pharmaceutical achronims.
Regulatory
Resources Library
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:
MedTech | Unlocking the power of Precision Medicine
Flyers
The Journey for ensuring regulatory compliance of Companion Diagnostics (CDx) in Pharma-Medtech nexus
eSubmission & Data Management Units
Flyers
ASEAN Submissions
Infographics
eSubmissions Training Courses
Flyers
Asphalion’s eSubmission services
Flyers
What you need to know for Submissions in Switzerland
Infographics
What you need to know for eCTD submissions in Australia
Infographics
What you need to know for eCTD submissions in China (NMPA)
Infographics
What you need to know about Taiwan (TFDA) submissions
Infographics
What you need to know about South African (SAHPRA) submissions
Infographics
What you need to know about Health Canada
Infographics
FDA Study Data
Flyers
Asphalion Medtech Solutions for UK & US
Flyers
EU Authorised Representative Medtech
Flyers
As your trusted partner and EU Authorised Representative Asphalion will guide you to comply with European regulations for Medical Devices and IVD
Asphalion’s Highlights: First quarter 2023
Highlights
Asphalion’s Highlights: First quarter 2023
Asphalion’s Highlights: Fourth quarter 2022
Highlights
Asphalion’s Highlights: Fourth quarter 2022
Structure-Data File Format (SD)
Flyers
Since 1st October 2022, applicants may now submit chemical structures as a single Structure-Data File format.
Are you holding a dossier in US? If the answer is YES, this brochure may be of your interest!
GULF COOPERATION COUNCIL (GCC) Regulatory Services
Infographics
Asphalion ensures that eCTD submission will always follow the most updated Module 1 GCC specifications and validation rules.
Bridging EU and US: IND preparation and submission
Case Studies
IND preparation and submission business case: A small European biotech company focused on drug discovery and development interested in engaging with the FDA.
Global portfolio Due Diligence
Case Studies
Business Case: A big EU pharmaceutical company, interested in acquiring a whole set of worldwide brands from a company.
Access Consortium
Flyers
The Access consortium is a medium-sized coalition of regulatory authorities from Australia, Canada, Singapore, Switzerland and the UK that work together to promote greater regulatory collaboration and alignment of regulatory requirements.
DADI webinar: Are you ready for Go-Live?
Webinars
DADI Webinar: Are you ready for Go-Live?
Regulatory Landscape in the UK: an update
Webinars
Regulatory Landscape in the UK: an update – Asphalion Webinar
Business Case eSubmission NDA
Case Studies
In this business case about an Asphalion eSubmission NDA, a Swiss Pharmaceutical company needed assistance with an initial complete NDA application, including datasets and SPL.
Asphalion’s Highlights: Third quarter 2022
Highlights
Asphalion’s Highlights: Third quarter 2022
RIM Implementation in times of IDMP
Webinars
RIM Implementation in times of IDMP – Asphalion Webinar
Asphalion’s Highlights: Second quarter 2022
Highlights
Asphalion’s Highlights: Second quarter 2022
The secret of Asphalion’s eCTD publishing success
RegTalks
The secret of Asphalion’s eCTD publishing success, a RegTalk with FMichael Shaub and Vicente Tur
How to set-up your Post-Market Surveillance and Vigilance system for IVDs according to IVDR
Webinars
How to set-up your Post-Market Surveillance and Vigilance system for IVDs according to IVDR – Asphalion Webinar
Asphalion & Covid 19
Infographics
Asphalion contributions to the fight against COVID-19
Efficient IDMP implementation in different sized pharma companies
Webinars
Efficient IDMP implementation in different sized pharma companies: practical experience and FAQs – Asphalion Webinar
DADI Q&A beyond the Q&A document
Webinars
DADI Q&A beyond the Q&A document webinar with Vicente Tur and Lourdes Martín (Asphalion)
Asphalion’s Highlights: First quarter 2022
Highlights
Asphalion’s Highlights: First quarter 2022
ISO IDMP: how does it change our current processes
Webinars
ISO IDMP webinar: how does it change our current processes
Veterinary Pharmacovigilance – New Regulation from 28 January 2022
Webinars
Veterinary Pharmacovigilance Webinar – New Regulation from 28 January 2022
Asphalion’s Highlights: Fourth quarter 2021
Highlights
Asphalion’s Highlights: Fourth quarter 2021
RIMS with Udo Griem (Körber Pharma Software)
RegTalks
Regulatory Information Management Systems (RIMS) RegTalk with Frank Dickert from Extedo
EUDAMED Module 2
Webinars
EUDAMED Module 2 Webinar with Lídia Cánovas and Francisco Rogríguez (Asphalion)
Towards a Smooth Transition to ISO IDMP
Webinars
Webinar: Towards a Smooth Transition to ISO IDMP
RIMS with Frank Dickert (Extedo)
RegTalks
Regulatory Information Management Systems (RIMS) with Frank Dickert from Extedo
Horizon Europe: New Challenges
RegTalks
Horizon Europe: New Challenges. RegTalks with Oriol Penon and Izabel Alfany (Leitat)
Key factors about the implementation of the new Clinical Trials Information System
RegTalks
RegTalks “Key factors about the implementation of the new Clinical Trials Information System (CTIS)” with Christopher Mann and Nuria Pazos
Horizon Europe – Prepare a succesful proposal
RegTalks
Asphalion RegTalks: Horizon Europe, Key aspects to prepare a succesful proposal
US IND Applications
Webinars
Webinar about US Investigational New Drug (IND) Applications
RIMS with Katrin Spaepen (VEEVA)
RegTalks
Regulatory Information Management Systems (RIMS) with Katrin Spaepen from VEEVA
RIMS with Steve Clark (ENOV)
RegTalks
Regulatory Information Management Systems (RIMS) with Steve Clark from ENOV
Asphalion’s Highlights: Third quarter 2021
Highlights
Asphalion’s Highlights: Third quarter 2021
Asphalion’s Highlights: Second quarter 2021
Highlights
Asphalion’s Highlights: Second quarter 2021
Asphalion’s Highlights: First quarter 2021
Highlights
Asphalion’s Highlights: First quarter 2021
Regional Submissions Atlas
Flyers
A guide to have an overview of regional submissions requirements
New Clinical Trials Regulation
Infographics
(CTR) No 536/2014
IND PROCEDURES Regulatory Assistance
Infographics
Medical Devices Legal Framework in UK after Brexit
Infographics
Medical Devices Scientific and Regulatory Services
Flyers
Asphalion provides comprehensive support during development, certification, registration and post marketing of Medical Devices, IVDs and Combination Products in Europe, US as well as other 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
Specialized standalone or integrated CMC solutions
Flyers
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. Small biopharmaceutical company with one
pharmaceutical product authorized through
a Decentralized Procedure in 10 European
countries.
The Client has all PV local activities
outsourced to different vendors in each
country, which poses several challenges.
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
.
Implementing a RIMS
White Papers
A whitepaper about how to select your perfect RIMS
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. A small European
Pharmaceutical company with
local activity in its country, with a
growth strategy aiming to
expand to international
markets but lacking experience
and capability in managing
complex EU procedures.
Medical Device Software Development
White Papers
The EU Regulatory Environment of Medical Device Software Development
