Life Sciences, as an industry is rapidly evolving, so does the Regulatory requirements to sustain in the industry.
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January 17, 2017 Pharmaceutical, Publishing & Submissions, Health Authority Updates -
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.
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Ever evolving Regulatory landscape, healthcare system reforms, and on-going technological advancements: with these factors influencing regulatory procedures at the most, the biggest task for life sciences organizations is to reduce the operational costs while managing the procedural efficiency for end-to-end compliance.
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July 20, 2016 Pharmaceutical, Publishing & Submissions, Health Authority UpdatesDo you know? The United States Food and Drug Administration (US FDA) has mandated that certain Regulatory submission types (NDA, BLA, and ANDA) should be filed in electronic Common Technical Document (eCTD) format beginning May 5, 2017.
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Identify the best suited software ahead of time
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Japan has a unique set of processes and agencies for the regulation of drugs. The Ministry of Health, Labour and Welfare (MHLW) and Pharmaceuticals and Medical Devices Agency (PMDA) are the two main Regulatory Agencies that oversee the approvals of the drugs as per the regulatory prerequisites in Japan.
Investigational New Drug (IND) Filing Process