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Pharmalex
About CRO
Regulatory affairs and pharmacovigilance services company providing drug safety, regulatory strategy, and compliance consulting across Europe.
Technology & Expertise
We have built Pharmalex's capabilities around Regulatory Affairs & Submissions, Pharmacovigilance & Safety Management, Drug Safety & Pharmacovigilance, Quality Assurance & Compliance. That expertise includes planning and delivery of regulatory documents across development milestones; pharmacovigilance operations, surveillance, and regulatory safety submissions; adverse-event management, safety surveillance, and benefit-risk support; and connected specialist capabilities, supported by program-specific methods, resources, and delivery planning.
Core Services
At Pharmalex, we deliver Regulatory Affairs & Submissions, Pharmacovigilance & Safety Management, Drug Safety & Pharmacovigilance, Quality Assurance & Compliance through flexible engagement models. Services may bring together regulatory strategy, dossier development, submission management, and authority support; safety case management, signal detection, medical review, and reporting; case processing, signal evaluation, aggregate reporting, and safety oversight; and connected specialist capabilities, allowing teams to expand or narrow support as a program evolves.
Accreditations & Compliance
Pharmalex manages compliance according to the regulations, methods, and locations relevant to each engagement. Facility credentials and certification scope are confirmed during qualification rather than assumed across the organization.
