Regulatory Solutions
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When Will Full Adherence To EU (536/2014) Be Required?
8/10/2022
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.
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Advarra - Advancing Clinical Research
6/10/2021
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.
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Regulatory Affairs Consulting
4/28/2021
Our regulatory affairs experts guide you through the entire drug development and regulatory submission process to help you achieve regulatory success.
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Pharmacovigilance And Safety Surveillance
4/24/2021
Delivering safety surveillance before and after regulatory approval for pre-approval and marketed health products.
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Marketing Applications For Regulatory Approval
4/23/2021
Preparing regulatory marketing applications to their successful conclusions is our focus.
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Institutional Biosafety Committee (IBC) Reviews
3/30/2021
IBC review involves the deliberate transfer of engineered genetic materials to human research subjects. Read our latest brochure on IBC review.
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PhlexEVMPD
2/19/2021
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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PhlexSubmission
2/19/2021
PhlexSubmission is a robust, highly configurable and easy-to-use publishing engine for electronic submissions such as eCTD, NeeS VNeeS but also it can provide paper publishing capabilities for CTD and any custom type submissions that might be required.
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PhlexRIM
2/19/2021
Comprehensive Phlexglobal Regulatory Information Management (PhlexRIM) will help the life sciences organizations effectively and efficiently drive the development, capture, dissemination, control and management of regulatory focused information throughout the product lifecycle.
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PhlexIDMP
2/19/2021
Start managing your IDMP data with Phlexglobal today! PhlexIDMP is a single regulatory database that will help you to avoid redundant data that exists within your submissions. PhlexIDMP is based on two key components - controlled vocabulary management and codes - that deliver the best ready to use IDMP management solution.