When Will Full Adherence To EU (536/2014) Be Required?
In January 2022, EU (536/2014) – a binding regulation across all members of the EU – came into effect. The new regulation will streamline procedures and remove duplication of single submission via a single EU portal. It also focuses on an assessment procedure leading to a single decision, rules on the protection of subjects and informed consent, a greater level of harmonization, and transparency requirements.
Advarra - Advancing Clinical Research
In this video, learn why Advarra is trusted by global clinical leaders to enable safety, compliance, & efficiency in their research. Advarra advances human health, by making clinical research safer, smarter, and faster.
Regulatory Affairs Consulting
Our regulatory affairs experts guide you through the entire drug development and regulatory submission process to help you achieve regulatory success.
Pharmacovigilance And Safety Surveillance
Delivering safety surveillance before and after regulatory approval for pre-approval and marketed health products.
Marketing Applications For Regulatory Approval
Preparing regulatory marketing applications to their successful conclusions is our focus.
Institutional Biosafety Committee (IBC) Reviews
IBC review involves the deliberate transfer of engineered genetic materials to human research subjects. Read our latest brochure on IBC review.
PhlexEVMPD is designed to support the collection, reporting, coding and evaluation of your medicinal product data in a standardized and structured way. Compliant with Article 57, PhlexEVMPD is a great and easy way to start managing and owning more and more of your data in a digitalized fashion.
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