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INDUSTRY NEWS AND PRESS RELEASES
 

Novo Nordisk Pharmatech A/S enters a distribution agreement with Signet Chemical Corporation Pvt. Ltd. for cGMP Quaternary Ammonium Compounds for pharmaceutical and medical device applications

Novo Nordisk Pharmatech A/S has entered into an agreement with Signet Chemical Corporation Pvt. Ltd. for the distribution of their pharmaceutical range of quaternary ammonium compounds (FEF® Quats) to the healthcare industry in India, Bangladesh and Sri Lanka. More>>

 
phone +45 5667 1000
email nnprinfo@novonordiskpharmatech.com
web www.novonordiskpharmatech.com
email Koebenhavnsvej 216, 4600 Koege
 

New to the PPMA Show 2018: Bright Ideas - Ambassador Programme

Expert knowledge to drive growth

A new initiative for PPMA Show visitors this year is the Bright Ideas - Ambassador Programme - a free advice service for start-up ventures and entrepreneurs. More>>

 
phone +44 (0)20 8773 8111
email sales@ppma.co.uk
web www.ppmashow.co.uk/
email NEC, Birmingham, UK
 

BioIVT to Focus on the Application of In Vitro Hepatocyte Models in Toxicology Research at the North American ISSX Meeting

Research using BioIVT’s TRANSPORTER CERTIFIED™ hepatocytes in sandwich culture and HEPATOPAC® technology in vitro liver models will be presented.

BioIVT, a leading provider of research models and services for drug development, today announced that it will be participating in several sessions at the 22nd North American International Society for the Study of Xenobiotics (ISSX) Meeting. This conference will be held from July 15-19 at the Palais des congrès de Montréal in Montréal, Canada. More>>

 
 

BioIVT Acquires Optivia Biotechnology, Adding Transporter Assay Products and Services to its ADME-Tox Portfolio

Acquisition strengthens BioIVT’s transporter sciences capabilities and enables it to partner with customers on new drug applications and mechanistic studies related to transporters.

BioIVT, a leading provider of research models and services for drug development, today announced that it has acquired Santa Clara, CA-based Optivia Biotechnology and its comprehensive portfolio of transporter assays, multi-transporter models, transporter systems biology, and molecular transport research solutions. More>>

 
 

BioIVT Webinar Will Discuss How to Optimize Microbiome Research

Sample collection and processing techniques play a crucial role in ensuring that research results represent the complete microbiome

BioIVT, a leading provider of research models and services for drug development, today announced that it is hosting a webinar entitled “The Microbiome: Understanding Why Collection and Processing Matters” at 11 a.m. ET on July 25. More>>

 
 

RWS Life Sciences Welcomes New VP of Quality

Clarice Streets joins RWS as VP of Quality for Life Sciences Division

RWS Life Sciences welcomes Clarice Streets, ASQ, CMQ, OE, as Vice President, Global Quality and Process, in charge of the strategic direction and implementation of its Quality system, underlying organizational processes, and change management. More>>

 
 
 
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News and Press Releases

Novo Nordisk Pharmatech A/S enters a distribution agreement with Signet Chemical Corporation Pvt. Ltd. for cGMP Quaternary Ammonium Compounds for pharmaceutical and medical device applications

Novo Nordisk Pharmatech A/S has entered into an agreement with Signet Chemical Corporation Pvt. Ltd. for the distribution of their pharmaceutical range of quaternary ammonium compounds (FEF® Quats) to the healthcare industry in India, Bangladesh and Sri Lanka.
More info >>


White Papers

Points to Consider When Developing a TMF (Trial Master File) Strategy

Phlexglobal Ltd

Many organizations are currently outsourcing clinical trial activities to one or more contract research organizations (CROs). This strategy enables companies to leverage specialized expertise and take advantage of flexible resourcing throughout the conduct of a clinical trial. Outsourcing minimizes the costs of recruiting experts, building a team and maintaining an infrastructure. However, it can also add complexity as the organization looks to meets its compliance obligations regarding clinical trial documentation. The documentation referred to in Article 15(5) of Directive 2001/20/EC as the trial master file shall consist of essential documents, which enable both the conduct of a clinical trial and the quality of the data produced to be evaluated.1 This essential study specific documentation is also known as the TMF. As organizations try to minimize their reliance on paper files, the electronic TMF (eTMF) has emerged. A current industry initiative to standardize the organization of this content is known as the TMF Reference Model. This model is helping standardization efforts across paper and electronic systems. As companies implement outsourcing strategies, CROs and sponsor organizations look for a common foundation on which to build their TMF capabilities. The following paper outlines some of the challenges organizations face when outsourcing clinical trial activities to multiple contract research organizations and a strategy to facilitate partnering and management of trial information between sponsors and CROs.
More info >>

Industry Events

Clinical Trial Supply Southeast 2018

2-3 October 2018, Cary, North Carolina

Clinical Trial Supply Southeast will return to Cary, North Carolina for fall 2018. Part of our global series of events, this show will attract the leading biotech and pharma companies from the Southeast region, the event will focus on how companies can adapt their supply chains to fit into the highly regulated world.
More info >>

 
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