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The Many Challenges of Narrative Writing

Narratives are an essential part of any programs’ story, but often become cumbersome due to the many challenges of narrative writing.

Thinking Beyond eCTD Publishing

While finding the right publishing vendor provides tremendous value to an organization short on internal resources, it is important to be thinking beyond eCTD publishing. Pairing with a vendor that can offer extensive regulatory and communications strategy, science and solutions experience brings numerous synergies.

Optimizing Regulatory Information Management

Optimizing Regulatory information management (RIM) is something every pharmaceutical company must plan for. Defining RIM can be a challenge, however, since there’s no ICH standard for what should be done. But right now your organization is dealing with the reality of managing several drug submissions weekly for multiple medicinal products. That includes keeping track of the regulatory activities associated with these submissions, attempting to manage agency commitments, and organizing and sharing the daily updates of agency correspondence. Without a central hub to capture critical regulatory data and turn that data into actionable intelligence, your business is at risk of missed deadlines, delayed market approval, and non-compliance.

DIA’s RSIDM Ask The Regulators Session: What We Learned

DIA’s Annual Regulatory Submissions, Information, and Document Management...

Tips For A Successful eCTD Conversion

With the May, 2018 FDA mandate quickly approaching, conversion of paper IND’s, NDA’s, and DMF’s to eCTD format must happen soon. Here are some tips for a successful eCTD conversion.

Is Your Company Prepared for the FDA eCTD Mandate?

Here we are in 2018, and to the surprise of some and the consternation of many, some paper applications are still alive and well. However, their days are numbered. The May FDA eCTD mandate is upon us. Is your company prepared to implement the FDA’s regulations for eCTD submissions of INDs, NDAs and DMFs?  

FDARA Marketing Status Reports Due

Time is running out for an item that may require your regulatory compliance attention. By law, FDARA marketing status reports are due on or before February 14, 2018.

Avoiding Policy 0070 Pitfalls and Ensuring Compliance

The European Medicines Agency (EMA) Policy 0070 guidance was initially...