Resources Hub

Welcome to the Asphalion Resources Repository

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Asphalion
MedTech Blog

A compilation of insightful articles on MedTech Regulatory Affairs.

Asphanet Pharmacovigilance Interactive Map

Asphanet Pharmacovigilance Interactive Map

Click on the countries to learn about the local safety requirements.

Glossary Of Pharmaceutical Regulatory Acronyms

Glossary of Pharmaceutical
Regulatory Acronyms

Comprehensive glossary that provides clear definitions of pharmaceutical achronims.

Global Pharmaceutical Regulatory Agencies Directory

Global Pharmaceutical
Regulatory Agencies Directory

Interactive directory of the main pharmaceutical regulatory agencies around the world.

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:

Cmc Week Video 1

VIDEO | The Outsourcing Trend in Regulatory CMC Activities

CMC Week
Cmc Week Articulo

ARTICLE | The relevance of Chemistry, Manufacturing and Controls (CMC) in drug development

CMC week
Cmc Week Business Case 1

BUSINESS CASE | Preparation of an IMPD for an ATMP product

CMC week
Cmc Week 2025 Flyer

FLYER | Driving Success Through CMC Due Diligence and GAP Analysis

CMC Week
Irp Video Lcm Week 1

International Recognition Procedure (IRP)

A must-watch for anyone involved in regulatory affairs or lifecycle management.
Revision Of The Medicines Variation Framework

INFOGRAPHIC | Revision of the Medicines Variation Framework

Additional National Procedures For Medical Devices

FLYER | Additional National Procedures for Medical Devices (AEMPS)

Additional National Procedures for Medical Devices in the Spanish Market
Business Case Lcm Week 0225

BUSINESS CASE | Supporting a company’s expansion and global growth

Fda Consultation Procedures

FLYER | FDA Consultation Procedures

Navigate FDA Requirements with Confidence
Design And Development For Medical Devices

FLYER | Design and Development for Medical Devices: Navigating ISO 13485

Design and Development (D&D) for Medical Devices
Fda De Novo Authorization Procedure

FLYER | FDA De Novo Authorization procedure

Overview ofthe De Novo Pathway
Iec 623042006 1

FLYER | Medical Device Software Standard IEC 62304:2006

Medical Device Software Standard IEC 62304:2006 /Amd 1:2015
Era Services 2025 2

LCM- Week | Electronic Application Form (eAF)

The Electronic Application Form (eAF) is a unified EU form used for human and veterinary MAAs, variations, and renewals. It combines PDF for input and XML for data transfer, enabling data import/export, auto-copy, self-validation, and access to standardized term catalogues (EUTCT)—streamlining regulatory submissions and reducing manual input.
Miniatura Youtube

VIDEO | First quarter 2025 highlights

We have compiled our quarterly highlights in a video for you to have an easy-to-scan summary of our newest insights
Regulation Eu 2017745

FLYER | Regulation (EU) 2017/745: Understanding its impact on Drug-Device Combinations in Directive 2001/83/EC

Drug–device combination products (DDCs) and how are they classified in Europe
Mastering The Safety Management Plan In Clinical Trials Recording

WEBINAR | Mastering the Safety Management Plan in Clinical Trials: Key points

Webinar recording

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