Optimizing Regulatory Information Management
Feb27

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.

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DIA’s RSIDM Ask The Regulators Session: What We Learned
Feb20

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

DIA’s Annual Regulatory Submissions, Information, and Document Management (RSIDM) Meeting is an excellent opportunity to learn the latest eCTD information and best practices. One of the most valuable sessions of the meeting is always the “Ask the Regulators” session, in which representatives from FDA answer questions directly from the attendees. This year, DIA scheduled two such sessions in addition to the FDA presentations on PDUFA...

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Tips For A Successful eCTD Conversion
Feb13

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.

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Is Your Company Prepared for the FDA eCTD Mandate?
Feb06

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?  

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Avoiding Policy 0070 Pitfalls and Ensuring Compliance
Dec21

Avoiding Policy 0070 Pitfalls and Ensuring Compliance

The European Medicines Agency (EMA) Policy 0070 guidance was initially issued in 2016 and since then has undergone several iterations. The evolving guidance adds complexities to the Marketing Authorisation Application submission process, challenging organizations to be agile with their teams and processes as they establish best practices and stay current with policy changes. Although Policy 0070 continues to be expanded for openness...

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Scanning, a Thing of the Past
Apr18

Scanning, a Thing of the Past

Nowadays the word “scan” is a bad word. Scanned documents are more difficult to read and often the quality is lower. Further, scanned documents do not allow search or copy and paste text. During an electronic review, the ability to search and cut and paste text are very useful. Sponsors are reporting more and more rejections if scanned documents are submitted.

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