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Company Description
ProPharma is a global life sciences partner that helps biotech, pharmaceutical, and medical device organizations bring safe, effective therapies to patients by simplifying complex challenges across the entire product lifecycle. For over 25 years, its more than 2,500 professionals have delivered an end-to-end suite of services spanning regulatory sciences, clinical research, quality and compliance, pharmacovigilance, medical information, functional service provider (FSP) resourcing, and digital transformation. ProPharmas regulatory sciences practice supports drugs, biologics, devices, and diagnostics with FDA and EMA strategy and submissions, expert meeting preparation, regulatory operations, advertising and promotional review, European Marketing Authorization Holder (MAH) services, lifecycle management, market access and reimbursement strategy, and nonclinical development. Its clinical research solutions provide full-service CRO capabilities, site and patient services, embedded solutions, global medical writing and transparency, and biostatistics and programming. The quality and compliance team delivers computer system validation (CSV), GxP compliance and auditing, inspection readiness, clinical quality assurance, commissioning, qualification and validation (CQV), program and project management, AI/ML quality and compliance, and healthcare compliance services. Pharmacovigilance offerings cover clinical and post-marketing safety, case management, safety systems, signal management, periodic safety reports and risk management plans, global literature review, global ICSR submissions, and QPPV/LPPV with regulatory intelligence. ProPharmas medical information group operates fully integrated 24/7/365 contact centers and provides adverse event and product complaint intake and follow-up, patient support and commercial services, medical communications, content management and translation, REMS and RMP support, and animal health services. Its FSP solutions supply specialized, managed expertise across clinical operations, data sciences, biostatistics, medical writing and quality control, and decentralized clinical trials, while digital transformation services address data strategy, technology enablement, validation, and compliance. With deep experience across oncology, obesity and diabetes, cardiovascular, CNS, respiratory, infectious disease and vaccines, ophthalmology, pediatrics, rare diseases, and cell and gene therapy, ProPharma delivers bespoke, fit-for-purpose
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