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Lindeq’s electronic PSMF solution
| By Lindeq
Find out more about our time saving, fully compliant PSMF solution, meeting all by the EMA and HMA required (quality) standards.
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Lindeq’s intelligent Quality Management System ItQMS
| By Lindeq
Have a look at our web-based ItQMS which includes document and training workflow, non-conformity reporting and easy controlled online access.
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Lindeq's Drug Safety Database incl. maintenance solution
| By Lindeq
Discover our solution we provide together with our safety database partner BaseCon.
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Quality by Design: Manufacturing at a Comprehensive GMP-Level
| By 3R Pharma Consulting
This whitepaper is Dr. Manuel Zahn’s presentation, 'Quality by Design'. This was delivered at the ,VISION PHARMA 2013, trade fair in Karlsruhe, Germany. 3R Pharma were present for the duration of the trade fair.
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Batch Control & Touch Technology
| By COPA-DATA
Wherever you are in the automation process, an interpretation is needed between the process engineers ‘instrument’ - the automation software and process equipment - and the process being controlled. The smooth operation and success of the process is based on the effective interpretation of the control system: from a digital representation into an analogue actuation in the real world.
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Operational Excellence (OPEX) through Optimization
| By COPA-DATA
As an automation supplier to many different industries, COPA-DATA sees how important mapping the process - and any connecting processes - in the visualization, and then presenting the information to the operator in the format most suited to them, can be in terms of efficiency gains. The operator influences the quality and efficiency of production.
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zenon in Pharma: Enhancing Pharmaceutical Production
| By COPA-DATA
COPA-DATA enhances pharmaceutical production with its sophisticated visualization software. And, through market penetration, zenon is gaining recognition for advanced pharmaceutical solutions. The rigors of regulation and validation, which impact on patient safety and business risk for the regulated producer, have been accommodated in zenon. Over the years, our customers’ experiences have informed the further streamlining and advancement of the product.
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PSN Brochure
| By PSN
psn is a full-service global Contract Research Organization (CRO) with over 200 employees in 11 offices across Northern America and Europe. We offer superior clinical development services to biotechnology, pharmaceutical companies and independent institutions acting as sponsors who wish to have a dedicated and cost effective partner.
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Right Place, Right Time
| By Centrical Global Limited
Guy Patrick of Centrical Global Limited discusses operational risk management, its application in the delivery of clinical trials, and how it can help to facilitate faster and better quality results.
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Comprehensive Feasibility Assessments in Eastern Europe - Luxury or Necessity?
| By Centrical Global Limited
Longer R&D timelines and the escalating costs of clinical trials, particularly in highly developed countries, has driven manypharmaceutical and biotechnology companies to examine the potential benefits of enrolling subjects in Eastern European countries. However, for many sponsors, operating in Eastern Europe can be a daunting prospect. In this article, we will examine how sponsors can be best positioned to take advantage of the benefits of emerging clinical trial locations.
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Chinese Regulatory Changes for Human Serum and Plasma Exports Trigger Potential Delays
| By World Courier
Researchers conducting or planning to conduct clinical trials in China should be aware of new regulatory changes that specifically affect export shipments of human serum and plasma from China and the delays that the new administrative process may create. This free white paper includes a list of these major changes associated with the new regulations.
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International Product Law Manual
| By Jardine Lloyd Thompson Limited
Jardine Lloyd Thompson Limited (JLT) was delighted to contribute to the recently published 'International Product Law Manual' by Kluwer Law International.
In addition to examining the current insurance environment for life science companies, this chapter will review the recent history of life science insurance and explain how we have got to where we are. It then identifies some of the main players, reviews the procurement process, identifies some typical policy wordings, and gives examples of how coverage can be impacted if attention to detail is not paid. The chapter then explores how claims are managed and set out practical issues to be aware of. Finally, the chapter explores recent developments that might influence the future of product liability insurance for life science companies.
*Arundel McDougall & Prashant Popat (eds), International Product Law Manual (copyright Kluwer Law International, 2010)

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