Phlexglobal Regulatory Services

ELEVATE YOUR REGULATORY CAPABILITIES

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).

Why Choose Phlexglobal Regulatory Services?

 

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SEASONED REGULATORY RESOURCES

Leverage experienced Regulatory professionals for submissions, RIM, and other data management initiatives.

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OPTIMIZE REGULATORY PROCESSES

Maintain registrations, enhance compliance and get products to patients more quickly.

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GET MORE FROM YOUR RIM SYSTEM

Leverage actionable regulatory data across your organization.

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Don't go it alone

Trust Phlexglobal to help with your submission

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.

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REGULATORY HEALTH CHECK

Assess Regulatory capabilities against leading practices and develop a roadmap for success

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IDMP READINESS

Access an IDMP Ramp-Up Program to facilitate a smooth transition from xEVMPD to IDMP

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Latest News

Smart Steps to Managing Your TMF Audit Trail

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,

Lowering the TMF temperature through quality reviews

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

Five-step Game Plan for a TMF Close-out

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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It's time to raise your standard 

CONTACT PHLEXGLOBAL TODAY
 
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