Recent Posts From All Categories

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...

Health Canada Revises Rules for eCTD Submissions

Health Canada recently announced revised validation rules for regulatory transactions for electronic Common Technical Document (eCTD) submissions.

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.

How to Interpret the Latest FDA Guidance on Manufacturing Establishment Information and its Relationship to IDMP Standards

The draft guidance on manufacturing establishment information coordinates all of the information about an establishment and its associated business operations into one structured format. The draft guidance states, “Electronic submissions of manufacturing establishment information (MEI) must include complete information on the locations of all manufacturing sites, including packaging and control sites, for both drug substance and drug product.”