We are a specialized provider of pharmacovigilance and regulatory science consulting services. Our unique understanding and up to the moment knowledge of what it takes to maintain compliance make us a preferred provider of compliance services to clients in small molecule pharmaceuticals as well as in biologics and advanced therapies.
Areas of excellence in Pharmacovigilance include PSMF, DSUR, PSUR, XEVMPD, RMP, Quality Systems, Literature Screening, Case Assessment, Signal Management and Case Reporting.
Areas of expertise in Regulatory Science: marketing authorizations in the EU, responses to deficiency letters from regulatory authorities, PIP Waiver / PIP Deferral, Orphan Designation, Scientific Advice, Protocol Assistance, Referrals PRAC, CHMP or CMDh, Medical Writing for Dossier Submission.
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