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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Pharma's growing interest in probiotics - a challenge or an opportunity?

According to the US FDA definition, probiotics are classified as Live Biotherapeutic Products (LBP) i.e. products that contain live organisms such as bacteria or yeast, found naturally in humans. The most common bacteria belong to the groups Lactobacillus and Bifidobacterium. Probiotics have a long global history of traditional use. Normally consumed through fermented foods and sold mostly as ingredients in foods or nutritional supplements. There is a thin line between nutritional supplements and drugs.

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Inspection 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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Considerations 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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When 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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Top 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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Tips 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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The 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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Monitoring 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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Implementation 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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QMS 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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Legal 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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Mutual 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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The medical device regulations and their implications on device vigilance

Download our recent whitepaper to gain deep insights into the medical device regulations and their implications on device vigilance.

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New 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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EU drug registration procedures

Download our recent whitepaper to gain deep insights into EU drug registration procedures.

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Preparing for a Good Pharmacovigilance Practice MHRA Inspection

Download our recent whitepaper to gain deep insights into preparing for a Good Pharmacovigilance Practice MHRA Inspection.

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Successful 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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Successful 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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EU Clinical Trial Regulation

Download our recent whitepaper to gain deep insights into EU Clinical Trial Regulation.

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How 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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In 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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Medical Device Software and Mobile Apps

Download our recent whitepaper which delivers deep insights about medical device software and mobile apps.

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Navigating 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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UK Pharmacovigilance Requirements Following the End of the Brexit Transition Period

Download our recent whitepaper which introduces you to the most important UK pharmacovigilance requirements following the end of the Brexit transition period.

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Non-clinical safety evaluation of vaccine: strategic considerations to accelerate clinical development

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.

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How will Medical Devices be regulated following the end of the Brexit Transition Period

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.

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Together 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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Brexit Considerations for Industry: The current Position

The UK formally left the EU on 31st January 2020 and the transition period, as set out in the withdrawal agreement, will come to an end on 31st December 2020. During this transition period the UK has continued to remain under EU pharmaceutical law. Our PharmaLex.perts have created an interesting Whitepaper, which introduces you to important current considerations about Brexit for the industry.

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Together 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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The 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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Analysis 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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The 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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Nitrosamines - information for MAHs

This paper gives details on the background and recommended steps required to ensure your medicinal products comply with the latest guidance for nitrosamines.

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Software, 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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Pre-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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Differing CMC requirements: US and EU

Different CMC regulatory requirements in various regions impose obstacles when considering expansion into other markets.

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Five 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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Manage effectively your Merger and Acquisition activities

Companies engaging in Merger and Acquisition (M&A) activities aim to gain momentum by undertaking one or a combination of the following to: Level of Regulatory Affairs Involvement with M&A Programs, Increase market share by consolidating their product portfolio into specific therapeutic areas, Replenish their previously dwindling product pipeline, Enter into emerging markets with existing and new products, Reduce costs through the consolidation of manufacturing sites.

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