HighTable- Gathering and Sharing Expertise
HighTable helps you gather and share expertise. In a world where everyone's connected, it's surprisingly difficult to find insights from people who know what they’re talking about. Would you rather go straight to the source or search the internet for hours? ... Regulatory Affairs > Suppliers TOPRA - Healthcare Regulatory Affairs
TOPRA is the global organisation for Regulatory Affairs professionals and for those who have an interest in Regulatory Affairs in the healthcare sector.... Regulatory Affairs > Suppliers 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. ... Regulatory Affairs > Suppliers Farfield Group - Analytical Instrument Systems
Farfield’s proprietary innovation Dual Polarisation Interferometer, (DPI) is an analytical instrument for label free, real time measurement for molecular systems and interactions. ... Regulatory Affairs > Suppliers A-Consult - Professional Regulatory Affairs and Drug Safety Services
A-consult offers professional assistance to the pharmaceutical industry within all areas of Regulatory Affairs and Drug Safety. ... Regulatory Affairs > Suppliers See more
Manufacturing Site Rationalisation 05 March 2012 | By Pharmalink Consulting
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 Change of Ownership Applications 05 March 2012 | By Pharmalink Consulting
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 Auto Injectors: From Planning to Launch 06 January 2012 | By SHL Group (Scandinavian Health Group Ltd.)
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 Performance Management in Medical Affairs 01 November 2011 | By Kinapse
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 Farfield Analight 4D Workstation 17 October 2011 | By Farfield Group
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 See more