Newsletter | January 9, 2013

01.09.13 -- Avoiding A Failed NDA Submission Via A Third-Party Gatekeeper

Pharmaceutical Online Newsletter
Discovery Research
Primary Process Development
Preclinical Development
Clinical Development
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Featured Focus: Preclinical Development
Avoiding A Failed NDA Submission Via A Third-Party Gatekeeper
By Diane Mauriello and William Cairns
Companies specializing in the development, registration, and manufacture of pharmaceuticals will require no less than flawless management of data and tactical tasks to meet stringent FDA NDA (new drug application) submission requirements. In the supercharged business and highly regulated life sciences industry, your company must engage the best skills and most highly experienced professionals who offer end-to-end solutions to assure that your new products will be brought to market as rapidly as possible, well managed, and with minimal risk.
Discovery Pathology: Molecular Tools And Biomarkers
Transgenic Animals In Preclinical Safety Testing
» Discovery Research
In Vivo Visions: A Look Inside Preclinical Research Using PET, SPECT, And CT
Molecular imaging is the visualization, characterization, and measurement of biological processes at the molecular and cellular levels in humans and other biologic systems. With a recent shift in established paradigms within drug development, the need for molecular imaging platforms is increasing.
Informatics For Neglected Diseases Collaborations
Managing Cell-Based Potency Assays
» Clinical Development
Incorporating Biomarker Research In A Real-World Setting
Using diagnostic tests to identify patients who would best benefit from particular therapies has long been the goal of many pharmaceutical research and development companies. Biomarkers have become an increasingly valuable tool to achieve this objective in the drug development process.
Sponsor, Site, And CRO Views On Best Practices In Clinical Trial Conduct
A Chief Medical Officer's Perspective On Selecting A CRO
Perceived Barriers To eCOA Adoption In Clinical Trials
The Future Of Cancer Clinical Trials Holds Promise Thanks To Oncolytic Viruses
» Primary Process Development
Kemwell: Biologics Becomes A Reality
A 100% family owned formulations contract manufacturer since 1980, Kemwell operates manufacturing facilities in Bangalore, India and Uppsala, Sweden. Customers include top pharmaceutical companies of the world — such as Allergan, Bayer, GSK, J&J, Novartis, Pfizer, and Teva.
» Packaging/Assembly
OEM Disposable Medical Device Outsourcing
Follow these ten tips to clearly define your needs and the function of the product. Your vendor may be able to suggest cost-efficient ways to improve product quality and lower unit price.
Choosing The Right Temperature Monitoring Solution
For Potent Product, Reliable Resource Is Required
Smart Cameras Track And Trace
» Logistics
The Urgent Need For Qualified Transportation Providers In Global Clinical Research
Given the high cost of conducting global clinical trials, and the even higher cost of failure, regulatory agencies and pharmaceutical companies alike now demand that every party involved in the pharmaceutical supply chain — transportation and logistics providers included — conform to GxP guidelines.
3 Keys To Mastering The Life Sciences Supply Chain With A 3PL
Quick International's Reliable Cold Chain Solution To Deliver Medical And Pharmaceutical Products
Too Big, Too Costly, Too Bad
How DHL Same-Day Shipping Saves Lives
Transportation In The Pharma Supply Chain: Understanding The Carrier Roles In A Logistics Environment