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LOGOS GmbH, a provider of regulatory services to pharmaceutical manufacturers, for $3.9 million in own common stock. [ 18 ] March 1999: Parexel acquires Groupe PharMedicom S.A. , a French provider of post-regulatory services to pharmaceutical manufacturers, based in Paris and Orléans and employing approximately 70 people, in exchange for ...
PPD was founded by Fred Eshelman, Pharm.D., as a one-person consulting firm in 1985. The following year, he expanded the company's scope to include development services and relocated operations from Maryland to North Carolina. July 1985: Fred Eshelman, Pharm.D., founds PPD as a one-person consulting firm based in his home in Maryland.
KCR is a clinical development provider for the biotechnology and pharmaceutical industries. It has three main service areas: Trial Execution, Consulting and Placement. KCR operates across four main regions: North America, Western Europe, Central Europe, and Eastern Europe, with a main operational hub located in Boston, MA, and other hubs in Berlin, Germany, Warsaw, Poland, Kyiv, Ukraine and ...
ICON plc is an Irish headquartered multinational healthcare intelligence and clinical research organisation that provides consulting, clinical development and commercialisation services for the pharmaceutical industry. [2] The company is listed on the Nasdaq stock exchange in the United States, and As of June 2023 had approximately 41,160 ...
The International Council on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use, a 2015 Swiss NGO of pharmaceutical companies and others, defined a contract research organization (CRO), specifically pertaining to clinical trials services as: [8]: 10 "A person or an organization (commercial, academic, or other) contracted by the sponsor to perform one or ...
Calyx, formerly Parexel Informatics, [5] is a corporate spin-off from Parexel International. [2] [6] Calyx is a British–American provider of biopharmaceutical services. [7]The company was formed in January 2021 following the strategic separation of the Parexel Informatics business from Parexel International, and provides medical imaging, e-clinical and regulatory services.
A stringent regulatory authority is a regulatory authority which is: a) a member of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), being the European Commission, the US Food and Drug Administration and the Ministry of Health, Labour and Welfare of Japan also represented by the Pharmaceuticals and Medical Devices Agency (as before ...
Regulatory affairs (RA), is a profession that deals with an organization’s adherence to regulatory compliance.. It is a position mostly found within regulated industries, such as pharmaceuticals, medical devices, cosmetics, agrochemicals (plant protection products and fertilizers), energy, banking, telecom etc. Regulatory affairs also has a very specific meaning within the healthcare ...
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