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July 17, 2023
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  How To Select a Contract Research Organization (CRO) for Your E&L Testing

The collection, interpretation, and utilization of extractables and leachables (E&L) data are not trivial processes, and the scientific and practical requirements for performing these activities may be beyond the technical and/or resource capacities of your organization. E&L assessments can be extensive and expensive, so a high level of diligence must be exercised in identifying, qualifying, and utilizing a CRO to perform your E&L studies.

Learn how to select the right CRO for the task.


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» Industry News
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  EMA Accepts Astellas' Marketing Authorization Application for Zolbetuximab
Astellas Pharma announced the European Medicines Agency (EMA) accepted the marketing authorization ... read more »
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  Dr. Reddy’s Proposed Rituximab Biosimilar Application Accepted by FDA, EMA and MHRA
Dr. Reddy’s Laboratories Ltd. announced that its Biologics License Application (BLA) for its ... read more »
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  BeiGene Announces FDA Acceptance of sNDA for Fifth BRUKINSA® Indication
BeiGene announced the FDA accepted for review the Company’s supplemental new drug application (sNDA)... read more »
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  FDA Approves First OTC Daily Oral Contraceptive
The FDA has approved Opill (norgestrel) tablet for nonprescription use to prevent pregnancy. This ... read more »

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» Infographic
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  Reducing Water Use in Pharmaceutical Manufacturing
This infographic summarizes why water use is so high in the pharmaceutical industry, gives a look at regulatory and corporate initiatives to lower ... read more »
» Featured Articles
EVENT   Data-Driven Science: How AI and Open Data will Revolutionize Scientific Discovery
Scientists have long been perceived and portrayed in films as old people in white lab coats perched at a bench full of bubbling fluorescent liquids. ... read more »
EVENT   Improving the Sterility Assurance Section of an Application to Allow for More Efficient Assessment of ANDA and NDA Submissions to the FDA
A goal within the FDA Division of Microbiology Assessment is to improve the quality of the sterility assurance submission for Abbreviated New Drug ... read more »
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» Featured Products
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  Klucel™ xtend Hydroxypropylcellulose (HPC) Controlled Release Matrix Former
Ashland Inc. Klucel™ xtend hydroxypropyl cellulose (HPC) is a controlled release matrix former, designed to ... learn more »
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  Aquarius™ Genesis Film Coating System
Ashland Inc. Aquarius™ Genesis film coating systems are designed for application at up to 35% solids, which can ... learn more »
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  Thermo Scientific™ Pharma 11 Twin-screw Extruder
Thermo Fisher Scientific Perform material- and labor-effective extrusion and granulation processes with the Pharma 11 Twin-... learn more »

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2465 Electrochemical Detector Learn More
arium basic Ultrapure Water Systems Learn More
C-660 Fraction Collector Learn More
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| Events
EVENT
  Microscopy and Microanalysis (M&M) 2023
Minneapolis, MN –  07/23/2023
Don't miss out on the premier microscopy education and networking event of the year – Microscopy and Microanalysis 2023 in Minneapolis, Minnesota!
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EVENT
  Temperature Control & Logistics North American Summit
Falls Church, VA –  09/19/2023
Join us at the Temperature Control & Logistics North American Summit as we cut through the complexity to identify which approaches will work for you, ...
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