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Regulatory intelligence is an integral part to exploit effectiveness and guidance for the regulatory professional, and is at the heart of every well-informed regulatory decision.
Can more than one drug name appear in a CCDS? Who is the proper party to approve CCDS updates and revisions?This articles offers a framework and helps in understanding the role of the cross-functional teams and their undertakings that are involved in creation of a CCDS.
FDA has established a unique device identification number (UDI) so as to suitably distinguish medical equipment through their usage and distribution. Even though this system is now fully implemented in human-and-machine-readable form, the UDI compliance timelines are quickly getting shorter for companies to effectively plan their GUDID submissions to FDA.
Back in 2012 a standard set of procedures, guidelines and agenda was established by Australia’s Therapeutic Goods Administration (TGA) in a bid to implement the submission of medicine applications using the electronic Common Technical Document (eCTD).
Drug Master File (DMF) is one of the important parts of the documents submitted to the regulatory authorities including the US Food and Drug Administration (FDA), the European Medicines Agency (EMA) and Japan’s Ministry of Health, Labor and Welfare (MHLW).
The Life sciences industry is undergoing a plethora of dynamic changes on a global scale as far as regulatory consulting engagement is concerned.
North Africa & Middle East
Australia & New Zealand
Japan & South Korea
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