The changing landscape of the life sciences industry makes it necessary for the companies to adapt to the global Regulatory requirements, immediately. Companies need to evolve themselves for the necessary transition with each mandatory requirement from the health authorities.
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December 30, 2019 Regulatory Affairs, Publishing & Submissions -
November 28, 2019 Regulatory Software & Services, Regulatory Affairs, Publishing & SubmissionsDrug development is an extensive and multifaceted process. In each phase of the development, manufacturers are obliged to demonstrate the safety and efficacy of their drugs in the form of Regulatory submissions. These submissions are intended to report how drug companies manufacture their drugs, design clinical trials, report safety findings, and create promotional material.
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December 20, 2018 Medical Devices, Regulatory Affairs, Publishing & SubmissionsEvery year, FDA regulates more than 190,000 medical devices pertaining to different classes. In order to provide better healthcare, the agency is striving continuously to update the pathways through which these devices are being submitted. In a recent press release, FDA announced that the agency is looking at the potential aspects to update the 510(k)-clearance pathway for medical devices.
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October 4, 2018 Regulatory AffairsAny modification to the drug substance manufacturing process such as facility / equipment changes, synthetic route changes etc. has the potential to affect the final drug product’s quality / efficacy / safety.
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November 3, 2017 Regulatory Affairs, Publishing & SubmissionsIn recent years there has been an unprecedented increase in the number of submissions of Abbreviated New Drug Applications (ANDAs) and 505 (b) (2) applications, mainly owing to the spurt in the number of follow-on insulins submitted via the 505 (b) (2) pathway and with a record increase of generic drug applications submitted and...
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September 29, 2017 Medical DevicesThe US Food and Drug Administration (FDA) has announced that it may release finalised guidelines for the device changes that would need a new 510(K) submission before 8th November, 2017.
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September 20, 2016 Consumer Healthcare, Cosmetics Regulatory Services, Regulatory Affairs, Health Authority UpdatesIn a recent announcement, the Food and Drug Administration (FDA) has established that the antiseptic wash products with certain (19 in number) active ingredients can no longer be marketed.
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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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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