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Healthcare Regulatory Affairs Outsourcing Companies

Healthcare regulatory affairs outsourcing companies play a vital role in assisting pharmaceutical, biotechnology, and medical device companies in navigating complex regulatory landscapes. These companies provide services related to regulatory strategy, submissions, compliance, and other aspects crucial for regulatory approval and market access.

Healthcare Regulatory Affairs Outsourcing Key CompaniesLatest Healthcare Regulatory Affairs Outsourcing Companies Update



  • January 2023: With the acquisition of Pharmalex, AmerisourceBergen broadened its international presence and commercialization operations. Amid the increasing regulatory complexities that pharma and biotech companies confront, AmerisourceBergen, a global healthcare organization, maintains its commitment to enhancing the assistance it offers its partners in order to facilitate patient access and optimize product success. PharmaLex, a multinational corporation with over 25 offices worldwide and its main office situated in Germany, is supported by a group of scientific, regulatory, and safety and compliance (GxP) specialists who offer regulatory assistance and strategic direction throughout the commercialization and development phases. The organization provides a comprehensive range of services, which encompass technology-enabled solutions, and cover every stage of the product lifecycle. These services include clinical development consulting, pharmacovigilance, quality management, and compliance.




  • May 2023: Abbott unveiled a series of new programs in May 2023 as part of a multimillion-dollar initiative to enhance care for under-represented populations and increase diversity in clinical trials. The augmentations to Abbott's Diversity in Clinical Trials initiative are predicated on scholarships, collaborations, and a commitment to patients from diverse backgrounds. Abbott utilized these in its internal clinical trials for the duration of the first year of the initiative. The organization formed a Diversity in Clinical Trials Medical Advisory Board within its inaugural year. It also sponsored over 300 fellowships at four medical institutions affiliated with historically black colleges and universities (HBCUs), in addition to the National Black Nurses Association and National Association of Hispanic Nurses, through the provision of $5 million in grants. Abbott and the Norton Healthcare Foundation introduced a novel initiative as part of this program expansion.


List of Healthcare Regulatory Affairs Outsourcing Key companies in the market

  • Accell Clinical Research, LLC

  • Charles River Laboratories International, Inc.

  • Clinilabs, Inc.

  • Criterium Inc.

  • ICON plc

  • Covance, Inc.

  • Medpace, Inc.

  • PAREXEL International Corporation

  • Pharmaceutical Product Development

  • (PPD) LLC

  • Promedica International

  • Quintiles Transnational Corporation

  • WuXi App Tec

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