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Manufacturing Site Rationalisation
Manufacturing site rationalisation initiatives are becoming increasingly important in the current times of increased merger and acquisition (M&A) activity and product divestment.
As pharmaceutical companies look to deliver short, medium and longterm efficiencies, the identification of potential synergies and efficiencies between multiple manufacturing sites has led to a marked increase in source transfer activities. This article reviews the numerous regulatory and logistical challenges and requirements inherent within a global manufacturing site rationalisation project.
Regulatory Affairs > White Papers
Regulatory Affairs > White Papers
Change of Ownership Applications
The transfer of marketing authorisations (MAs) from one legal entity to another is a common part of merger and acquisition activity within the pharmaceutical industry. While this is usually a fairly straightforward regulatory process it is often complicated by commercial and stock control issues. It is further complicated by the variety in the procedures to be followed market by market in terms of documentation, timescale for approval and implementation requirements. This article gives a flavour of how to handle projects of this nature, with some specific country examples to highlight the diversity of processes.
Regulatory Affairs > White Papers
Regulatory Affairs > White Papers
Auto Injectors: From Planning to Launch
SHL is officially introducing the company’s first White Paper on the topic of 'Auto Injectors; From Planning to Launch' with the goal of sharing with readers insights on how to prepare for the overall development process from different perspectives including design, regulatory and manufacturing.
Regulatory Affairs > White Papers
Regulatory Affairs > White Papers
Performance Management in Medical Affairs
As Medical Affairs evolves and takes a more prominent role in the development and commercialisation of medicines, it needs a more robust approach to performance management. However, Medical Affairs must first be def ined in a way that is clear to all
internal stakeholders. A definition of Medical Affairs accountabilities and deliverables which is supported by robust KPIs will help to align the Medical Affairs organisation, and importantly enhance cross-functional collaboration in the achievement of the goals of the business.
Regulatory Affairs > White Papers
Regulatory Affairs > White Papers
Farfield Analight 4D Workstation
Supremely sensitive, the Farfield Ana Light® quantifies real-time protein conformational changes and membrane structure, to reveal the mechanisms underpinning biomolecular interactions.
Regulatory Affairs > White Papers
Regulatory Affairs > White Papers
Ideas About the Future of the Innovative Pharmaceutical Industry
Download our latest white paper here.
Regulatory Affairs > White Papers
Regulatory Affairs > White Papers
Efficient Drug Registration Process Based on Document Management
In today’s extremely complicated regulatory environment, which is becoming even more complicated by the hour, it is no longer possible to meet challenges of tomorrow with yesterday’s tools. Mountains of paper, the brand of every regulatory affairs department for so long, are bound to disappear. In the new, mostly electronic environment, the quality of a software solution will increasingly become the comparative advantage on the drugs’ long journey from an idea to the market.
Regulatory Affairs > White Papers
Regulatory Affairs > White Papers
EDMS Based Development Documentation: Decreased Time to Market
Processes in pharmaceutical development departments are mostly serving drug development projects. Documents resulting from these processes normally describe the process milestones. By means of applying the right set of attributes to each document, project management and reporting could be made much easier and less time-consuming.
Regulatory Affairs > White Papers
Regulatory Affairs > White Papers
EDMS Based QA/QC Documentation: the Lasting Answer to GxP Challenges
In all GxP areas, document handling is one of the most exposed areas when it comes to regulatory inspections. While good document management system cannot by itself ensure the favourable result of an inspection, the lack of it is almost sure to ruin the company’s high expectations, even if there is nothing essentially wrong with the presented data. In order to deal with all the documentation pertinent to the challenges in GxP environment, INFOTEHNA developed QualityExpert. QualityExpert is the solution based on INFOTEHNA proprietary application myProcess, which ensures the compliance with all regulatory requirements, including 21CFR11. In addition, myProcess is the base for all other INFOTEHNA myPharmaExpert Suite solutions, which ensures 100% cross-solution compatibility.
Regulatory Affairs > White Papers
Regulatory Affairs > White Papers
Efficient Pharmacovigilance Process Based on Document Management
Each company has to establish a pharmacovigilance system, with the primary aim of ensuring timely gathering, analyzing and submission of safety concerns. This documentation is the primary target for any pharmacovigilance audit and thus has to be maintained in a way similar to GMP documentation.
INFOTEHNA solution provides profiles for all of the necessary documents, with predetermined templates, lifecycles, workflows and roles.
Regulatory Affairs > White Papers
Regulatory Affairs > White Papers
Big Pharma R&D – thinking big, acting small
The pharmaceutical industry is experiencing an extended phase of consolidation in an attempt to realise economies of scale and mitigate risks. Kinapse analysis suggests that Big Pharma might now be too big and shows how to break it into smaller operating entities to help increase R&D productivity.
Regulatory Affairs > White Papers
Regulatory Affairs > White Papers
Earned Value Management, an approach for effectively managing pipeline value
Life sciences R&D organisations have made advancements in managing the performance of their development projects and portfolios, yet prioritisation, resource and budget allocation, and the tracking of value creation remain hard to achieve. This article argues that life sciences R&D organisations should adopt EVM, describes the benefits of applying EVM at the project level, and explores the potential for additional benefits at the portfolio level.
Regulatory Affairs > White Papers
Regulatory Affairs > White Papers
Discovery Metrics – Creating the Right Balance
Metrics can be powerful tools for driving performance, but the measurement of effort and output in Discovery organisations is often felt to be in fundamental conflict with the need for the creative, unconstrained culture required to drive innovation. In addition, many would argue that Discovery metrics largely fail to yield benefits. This paper explores the reasons behind that, and looks at an approach to defining metrics that are ‘fit for purpose’.
Regulatory Affairs > White Papers
Regulatory Affairs > White Papers
Internet usage of Indian General Practitioners
General Practitioners (GPs) form a vital part of the medical fraternity in India and are a major part of the pharmaceutical companies’ prescriber base. A rapid development has taken place in the use of Internet by the medical fraternity in India over a past few years and pharmaceutical companies have been making a lot of efforts to use Internet as a channel to connect to GPs both for marketing their products as well as knowledge sharing. A survey was conducted involving more than 100 GPs across 3 Indian cities to evaluate opinions and perceptions of the Indian GPs on their professional use of Internet. This paper tries to analyse their opinions and provide recommendations on how the industry can further use Internet to improve their reach to GPs.
Regulatory Affairs > White Papers
Regulatory Affairs > White Papers
In Regulatory Affairs
Regulatory Affairs Intelligence
Streamlining and Accelerating Change Control
Published by QUMAS
Regulatory Affairs > White Papers
Introducing the DAI Auto-Injector
Published by SHL Group (Scandinavian Health Group Ltd.)
Regulatory Affairs > White Papers
Efficient Drug Registration Process Based on Document Management
Published by Infotehna Group
Regulatory Affairs > White Papers
Quality by Design - Putting Principles into Practice
Published by Parenteral Drug Association (PDA)
Regulatory Affairs > White Papers
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Nanotechnology in Drug Delivery - Technological Improvements and Novel Approaches to Fulfill High Potential
GBI Research, the leading business intelligence provider, has released its latest report, “Nanotechnology in Drug Delivery - Technological Improvements and Novel Approaches to Fulfill High Potential” that provides key data, information and analysis of the major trends and issues affecting the global nano-enabled drug delivery market. The report provides a comprehensive insight into the current and future application of nanotechnology in the drug delivery systems. It also provides an insight into the key drivers and barriers for the market growth. The report also provides a detailed analysis of the trends and its effects on the nano-enabled drug delivery market. The report also talks about the key regulations that affect the nanotechnology research and development and issues related to its use in pharmaceutical market. The report also details some case study of the latest technology being exploited in pharmaceutical industry. The report also provides detailed analysis of major deals that have happened in the nano-enabled drug delivery market landscape. At the end, the report looks into the future players. This report is built using data and information sourced from proprietary databases, primary and secondary research and in house analysis by GBI Research’s team of industry experts. The nano-enabled drug delivery market has been a high growth market and expected to grow at a faster rate in the near future. According to a study conducted by Willi Paul, and Chandra P. Sharma, the nano-enabled drug delivery market was $1.7 billion in 2009 and expected to reach over $4.8 billion in 2012. The market will witness increased competition, high investment from venture capitalist and government. The M&A and Licensing landscape will see significant changes in the coming future. This is because market is expected to become more lucrative in coming future. The major drivers for the market growth are Increasing acceptance of nano-enabled drugs, and a strong pipeline portfolio. The increasing governmental funding and R&D interest will strengthen the market in future. However, lack of consistent policy on technology transfer, poor R&D facility, and tight audit control and lack of centralized system will restrain the market growth. The nano-enabled drug delivery market has strong pipeline. The pipeline is primarily dominated by molecules in early stage of development. This suggests that the there is high level of R&D investment. This will support the future market and will fuel the licensing activity. Buy online from $3500
GBI Research, the leading business intelligence provider, has released its latest report, “Nanotechnology in Drug Delivery - Technological Improvements and Novel Approaches to Fulfill High Potential” that provides key data, information and analysis of the major trends and issues affecting the global nano-enabled drug delivery market. The report provides a comprehensive insight into the current and future application of nanotechnology in the drug delivery systems. It also provides an insight into the key drivers and barriers for the market growth. The report also provides a detailed analysis of the trends and its effects on the nano-enabled drug delivery market. The report also talks about the key regulations that affect the nanotechnology research and development and issues related to its use in pharmaceutical market. The report also details some case study of the latest technology being exploited in pharmaceutical industry. The report also provides detailed analysis of major deals that have happened in the nano-enabled drug delivery market landscape. At the end, the report looks into the future players. This report is built using data and information sourced from proprietary databases, primary and secondary research and in house analysis by GBI Research’s team of industry experts. The nano-enabled drug delivery market has been a high growth market and expected to grow at a faster rate in the near future. According to a study conducted by Willi Paul, and Chandra P. Sharma, the nano-enabled drug delivery market was $1.7 billion in 2009 and expected to reach over $4.8 billion in 2012. The market will witness increased competition, high investment from venture capitalist and government. The M&A and Licensing landscape will see significant changes in the coming future. This is because market is expected to become more lucrative in coming future. The major drivers for the market growth are Increasing acceptance of nano-enabled drugs, and a strong pipeline portfolio. The increasing governmental funding and R&D interest will strengthen the market in future. However, lack of consistent policy on technology transfer, poor R&D facility, and tight audit control and lack of centralized system will restrain the market growth. The nano-enabled drug delivery market has strong pipeline. The pipeline is primarily dominated by molecules in early stage of development. This suggests that the there is high level of R&D investment. This will support the future market and will fuel the licensing activity. Buy online from $3500
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Pharmalink Consulting - Regulatory Affairs Consultancy
We provide Regulatory Affairs support services to Healthcare companies globally. Our services cover the full product life-cycle, from pre-approval to licence maintenance and compliance activities. Our Clients benefit from our top-quality interim Regulatory Affairs staffing solutions and Consultancy Services.
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