For the betterment of healthcare enabling the end user get ultimate benefits of safety and efficacy, there is always a reserved space for invention in the field of medical devices. With the technological development, medical device manufacturers are always on their toes to come up with the best possible innovative products.
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March 28, 2017 Medical Devices, Publishing & Submissions -
March 21, 2017 Publishing & Submissions, Health Authority UpdatesAhead of nearing mandatory eCTD deadline, 5/5/2017, to clear the confusion surrounded, the Food and Drug Administration (FDA) of United States has clarified what exactly it is looking for in the Type III Drug Master File (DMF) submissions.
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February 28, 2017 Publishing & Submissions, Health Authority UpdatesAs we all are aware, the United States Food and Drug Administration’s (US FDA’s) electronic Common Technical Document (eCTD) requirement is nearing the deadline.
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February 3, 2017 Publishing & Submissions, Health Authority UpdatesWhat does it mean for Drug Approval Processes?
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January 17, 2017 Pharmaceutical, Publishing & Submissions, Health Authority UpdatesLife Sciences, as an industry is rapidly evolving, so does the Regulatory requirements to sustain in the industry.
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January 10, 2017 Pharmaceutical, Publishing & Submissions, Health Authority UpdatesThe latest announcement from the Danish Medicine Agency (DMA) specifically points out elimination plan for NeeS format and emphasizes the consequent transition to eCTD for human domain / VNeeS for veterinary domain as directed in the eSubmission Roadmap.
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Regulatory Guidelines for the Pharma Industry, so far in ‘16
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November 30, 2016 Publishing & Submissions, Health Authority UpdatesAre you planning for clinical or non-clinical studies post December 17, 2016? If yes, we suggest you take a look at Food and Drug Administration’s (FDA’s) study Data standards applicable for certain types of submissions to CDER and CBER.
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November 23, 2016 Publishing & Submissions, Health Authority UpdatesIn the October released guidance, Medicines Control Council (MCC) has given clarity for manufacturers who are willing to submit applications for medicine registrations in electronic common technical document (eCTD) format. The guidance mainly emphasized the implementation timelines o
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November 15, 2016 Pharmaceutical, Publishing & Submissions, Health Authority UpdatesWhen it comes to dossier submissions for medicine registrations, each country has its own Regulatory data requirements which should be submitted in set formats and templates. Likewise, dossier submissions towards South African market has specific format to be considered.