Parexel (Regulatory Consulting)
Durham, NC; global · United States
Specialization: Regulatory strategy, submissions, market access
Key Differentiator
World-class regulatory consulting within full-service CRO
Core Services
Regulatory strategy & consulting; IND/NDA/BLA/MAA submissions; eCTD publishing; FDA/EMA interactions; Labeling; Medical writing; Pharmacovigilance
Capabilities
Market Intelligence
World-class regulatory consulting within full-service CRO. Deep FDA/EMA expertise.
Website
https://www.parexel.comSimilar Companies
ArisGlobal
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AI-native PV technology platform; LifeSphere automates case processing reducing manual effort by 70%+; cloud-native SaaS
Navitas Life Sciences (TAKE Solutions)
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Part of TAKE Solutions (BSE listed); strong Health Canada regulatory expertise; integrated PV + regulatory + clinical services
PharmaLex (US)
Waltham, MA + global · Regulatory strategy, PV, quality management
Leading pure-play regulatory specialist
ProPharma Group
Overland Park, KS · Lifecycle regulatory, pharmacovigilance, quality
World's leading regulatory sciences consulting firm; acquired Clinres Farmacija (Jan 2024) + iSafety Systems (Feb 2024); Clinical Trials Excellence Award 2024; end-to-end from clinical PV through post-marketing
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