Life Sciences companies face increased regulatory scrutiny while navigating the complexity of constantly evolving country and region-specific regulations. Phlexglobal helps teams assess current Regulatory capabilities, and design, plan and implement compliant processes (EUMDR, UDI, IDMP).
Leverage experienced Regulatory professionals for submissions, RIM, and other data management initiatives.
Maintain registrations, enhance compliance and get products to patients more quickly.
Leverage actionable regulatory data across your organization.
Submissions and other regulatory correspondences are moving more and more towards electronic formats. In fact, some submission types are mandatory to be submitted in electronic formats and others are following quickly. If you are either moving from paper based submissions towards electronic formats or are just seeking help in managing your electronic submission lifecycle, our regulatory experts are glad to help you achieve your tasks and meet your deadlines.
To create and manage your submissions, we are using our Phlexglobal Regulatory Platform, which allows us to share documents and submissions with you in a secure manner during the creation process, allowing you to review and participate in the process if needed.
The term audit trail can be daunting for companies, but this is a regulatory requirement. Simply put, when it comes to the trial master file (TMF), if an action is not recorded in the audit trail,
We are thrilled to announce Season 2 of our exciting webinar program, Summer Shorts: TMF Excellence Edition! Avoid boring summer reruns and attend these fresh, informative sessions where our experts
Close-out of a clinical trial raises many questions about responsibility and management of the trial master file (TMF). According to ICH E6 (R2), final close-out can only occur when the monitor – or
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