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Managing mature product portfolios - Key challenges and benefits
According to PwC, some large pharma companies have reported as much as 40% of their spend will be subcontracted and that their clinical operations functions will eventually be entirely outsourced. These companies have vast portfolios which require on-going maintenance to ensure continued compliance.
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DownloadInspection Readiness Audit - Gap Analysis - Mock Inspections
Maintaining regulatory compliance across the product lifecycle, from product development through commercialisation and market compliance, is critical to ensuring the continuity of your operations. Whether your organisation is virtual or fully in-house, auditing is a mandatory component of maintaining regulatory compliance.
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DownloadConsiderations When Applying for a Generic Medicine Authorisation
It is estimated that over 80% of prescribed medicines in the UK are generic medicines, yet they account for only one-third of the total market value. Why?
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DownloadWhen your notified body is losing its designation under the medical device regulation
Download our recent whitepaper to gain deep insights into when your notified body is losing its designation under the medical device regulation and how to effectively prepare for the change.
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DownloadTop tips for a successful EU Orphan Drug Designation application
Download our recent whitepaper to gain deep insights into the top tips for a successful EU Orphan Drug Designation application.
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DownloadTips for writing an outstanding Clinical Overview
Download our recent whitepaper to gain deep insights into how to write an outstanding Clinical Overview.
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DownloadThe Medical Literature Monitoring of the EMA
Download our recent whitepaper to gain deep insights into the Medical Literature Monitoring of the EMA.
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DownloadMonitoring Compliance with Safety Exchange Agreements
Download our recent whitepaper to gain deep insights into the Monitoring Compliance with Safety Exchange Agreements.
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DownloadImplementation of Eudravigilance Data Analysis System (EVDAS) in signal detection
Download our recent whitepaper to gain deep insights into the Implementation of Eudravigilance Data Analysis System (EVDAS) in signal detection.
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DownloadQMS aspects of the Medical Device Regulation
Download our recent whitepaper to gain deep insights into the QMS aspects of the Medical Device Regulation.
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DownloadLegal status switches in the UK
Download our recent whitepaper to gain deep insights into the legal status switches in the UK.
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DownloadMutual recognition of inspections of medicinal product manufacturers between the EU and the USA
Download our recent whitepaper to gain deep insights into the mutual recognition of inspections of medicinal product manufacturers between the EU and the USA.
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DownloadNew responsibilities for importers
Download our recent whitepaper to gain deep insights into the new responsibilities for importers, distributors and authorized representatives for medical devices.
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DownloadEU drug registration procedures
Download our recent whitepaper to gain deep insights into EU drug registration procedures.
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DownloadSuccessful marketing of medicinal cannabis and cannabis-derived products - Part II
Download our recent whitepaper to gain deep insights into Successful marketing of medicinal cannabis and cannabis-derived products.
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DownloadSuccessful marketing of medicinal cannabis and cannabis-derived products
Download our recent whitepaper to gain deep insights into Successful marketing of medicinal cannabis and cannabis-derived products.
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DownloadEU Clinical Trial Regulation
Download our recent whitepaper to gain deep insights into EU Clinical Trial Regulation.
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DownloadHow will clinical trials be regulated after 1 January 2021?
Download our recent whitepaper so that after reading you will have an answer to the question ‘How will clinical trials be regulated after 1 January 2021?’.
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DownloadIn Vitro Diagnostic Medical Devices Regulation – Summary of changes and impact for manufacturers
Download our recent whitepaper which delivers deep insights about In vitro diagnostic medical devices regulation – summary of changes and impact for manufacturers.
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DownloadMedical Device Software and Mobile Apps
Download our recent whitepaper which delivers deep insights about medical device software and mobile apps.
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DownloadNavigating the regulatory submission process for a class III medical device with ancillary medicine
Download our recent whitepaper which helps you navigating the regulatory submission process for a class III medical device with ancillary medicine.
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DownloadTogether Beyond COVID-19: Key trends that have been accelerated by the pandemic
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.
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DownloadTogether Beyond COVID-19 - A Look at the Future
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.
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DownloadThe Medical Device Regulation – Readiness for May 2021
This paper highlights what medical device manufacturers and other Economic Operators must be aware of ahead of the revised May 2021 deadline.
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DownloadAnalysis of EMA's Product Management Services
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.
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DownloadThe Challenges of Achieving and Maintaining CMC Compliance
This paper highlights just a few key points that need consideration ahead of achieving and maintaining CMC Compliance in a more sustainable way.
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DownloadSoftware, AI and Medical Devices - What's Up?
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.
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DownloadPre-IND meetings | The opportunity for early FDA feedback
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.
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DownloadDiffering CMC requirements: US and EU
Different CMC regulatory requirements in various regions impose obstacles when considering expansion into other markets.
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DownloadFive secrets of great publishers
The FDA’s mandate for life science companies and manufacturers to submit information in electronic
format has solidified the Regulatory Publisher’s function as being essential to the drug development
process.
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