Blog & Article
- 7th May 2024
White Papers
White Paper
Download our recent whitepaper which delivers deep insights about In vitro diagnostic medical devices regulation – summary of changes and impact for manufacturers.
White Paper
Download our recent whitepaper which delivers deep insights about medical device software and mobile apps.
White Paper
Download our recent whitepaper which helps you navigating the regulatory submission process for a class III medical device with ancillary medicine.
White Paper
Download our recent whitepaper on Non-clinical safety evaluation of vaccine and gain valuable insights about the step-wise process comprising preclinical proof of concept, non-clinical development (efficacy, quality, and safety), and clinical development of a vaccine.
White Paper
This whitepaper summarises the key elements of MHRA’s guidance document on medical devices, regarding registration, assessment procedures, labeling, post-market surveillance, and vigilance that will apply for devices placed on the market in Great Britain (England, Wales, and Scotland) and Northern Ireland. This document provides a list of actions that manufacturers of medical devices should take in order to continue the placement of their products on the EU and UK markets.
White Paper
Coronavirus has shattered our world and changed nearly all aspects of our lives. It has also changed our relationship with healthcare. It is slowly becoming a cliché to say that COVID-19 has catalyzed life sciences and healthcare trends – but nevertheless, it’s true. Industry leaders and PharmaLex experts recently discussed the key trends being accelerated since the start of the COVID-19 pandemic. This paper summarizes the main points of their discussions as well as the possible implications of these trends.
White Paper
In cooperation with EY, open-ended interviews were conducted with top pharmaceutical companies around Europe to understand the challenges that the pharmaceutical industry faces during COVID-19. This paper summarizes the main highlights, together with the future vision.
White Paper
This paper highlights what medical device manufacturers and other Economic Operators must be aware of ahead of the revised May 2021 deadline.
White Paper
This paper gives details on the background and recommended steps about the Analysis of EMA’s Product Management Services, the current Implementation Guide and future Development.
White Paper
This paper highlights just a few key points that need consideration ahead of achieving and maintaining CMC Compliance in a more sustainable way.
White Paper
This paper highlights just a few key points that need consideration ahead of the new Medical Device Regulation 2017/745 (MDR) being implemented in 26th May 2020.
White Paper
This first meeting establishes the tone of your Agency relationship, and as one of the desired outcomes, you want the Agency to gain respect for your company and your science.