Lonza expands manufacturing with bottling and labeling at US site
WEBAug 15, 2024 · Lonza boosts clinical services with new bottling capabilities. Lonza, a global leader in the pharmaceutical, biotech, and nutraceutical markets, has announced a significant expansion of its clinical manufacturing services at its small molecules site in Bend, Oregon. The upgrade includes the installation of advanced bottling and labeling ...
Extractables and leachables analysis of pharmaceutical products
WEBFeb 29, 2024 · The FDA defines extractables and leachables as follows: 2 . Extractables: Organic and inorganic chemical species that can be released from the surfaces of components used in the manufacture and storage of drug products under laboratory conditions (accelerated or exaggerated temperatures, solvents or surface exposure).
Premier Research: holistic approach benefits development
WEBOct 6, 2020 · Holistic design starts off with designing a target product profile that considers the end goal early in the development planning. Also, part of a successful holistic approach, Sharif suggested, is asking thoughtful, appropriate questions at the outset, making sure to consider outcome-focused impactful issues at every stage of development.
The role of dissolution in drug development
WEBOral dosage forms remain one of the most flexible and effective treatments available to patients. Dissolution testing is a requirement for all solid oral dosage forms and is used throughout the development life-cycle for product release and stability testing. It is a pivotal analytical test used for detecting physical changes in an active pharmaceutical ingredient and formulated product
McKesson completes RxCrossroads acquisition
WEBJan 8, 2018 · McKesson Corporation has completed its acquisition of RxCrossroads to support customer needs beyond channel distribution as the industry faces increasing challenges. The supply chain management solutions company purchased RxCrossroads – a Kentucky-based specialty solutions provider – from CVS Health Corporation in a deal valued at $735m ...
The rise of the integrated research organization: A conversation …
WEBSep 11, 2019 · Behind the term is NC-based Javara, which made its official debut in June 2018 . The company’s CEO Jennifer Byrne told us the name ‘integrated research organization,’ or IRO, emerged as the descriptor for the new clinical research model following discussions with Wake Forest Baptist Health.
BioCelerate, FDA forge nonclinical data partnership
WEBJun 10, 2021 · BioCelerate—a company that works on various solutions to improve efficiencies in nonclinical research to elevate drug development--has released its first set of resources created via its public-private partnership (PPP) with the US Food and Drug Administration’s (FDA’s) Center for Drug Evaluation and Research (CDER) Office of ...
Sanofi unveils EUROAPI as name of new API company
WEBJan 14, 2021 · Sanofi has unveiled EUROAPI as the name of its new European active pharmaceutical ingredients (API) company. Additionally, the firm has appointed Karl Rotthier as its future CEO. According to Sanofi, the new company stands to be the largest API organization in the European Union, with projected sales …
Covance bolsters pharmacovigilance services with Sciformix …
WEBJun 12, 2018 · Covance, LabCorp’s contract research organization (CRO) business, has acquired Sciformix Corporation, a scientific process outsourcing company focused on pharmacovigilance and regulatory solutions. “Sciformix enhances Covance’s offering, particularly in post-approval pharmacovigilance. Its …
ICON to acquire PRA Health Sciences in $12b deal
WEBFeb 25, 2021 · ICON, a Dublin-based contract research organization (CRO) has entered into an agreement to acquire PRA Health Sciences, another CRO currently sited in Raleigh, North Carolina. The arrangement comprises a cash and stock transaction valued at approximately $12bn USD. According to company leaders, the transaction stands to benefit pharmaceutical ...
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