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 Trial Master File (TMF) has evolved from a repository of documents at the end of a study to an integral cog in the regulatory journey. This has led some companies to shift their perspective from
Rewind the clock and take TMF back to basics: The paradigm of maintaining simplicity while embracing technology. In 20 years, the Trial Master File (TMF) has moved from paper in dusty lever arch
Migrating Trial Master File (TMF) data is a fairly common occurrence, usually driven by one or more of the following scenarios: Implementing a new electronic Trial Master File (eTMF) system
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