The life sciences industry is ever-changing and evolving. It’s the same in the year 2018. A lot of mandatory changes have been made to the regulations, and a lot of guidance documents have been released pertaining to the best Regulatory practices of consumer healthcare, medical devices, pharmaceuticals, which are expected to impact the industry in a positive way.
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December 27, 2018 Regulatory Artwork Services, Food and Food Supplements, Compliance, Audit and Validation, Consumer Healthcare, Cosmetics Regulatory Services, Medical Devices, Pharmaceutical, Registration Strategy, Regulatory Intelligence, Regulatory Labeling, Regulatory Software & Services, Regulatory Affairs, Market Access, Regulatory Consulting, Publishing & Submissions, Regulatory Medical Writing, Health Authority Updates -
January 17, 2018 Consumer Healthcare, Health Authority UpdatesAbout a year after issuing the final rule for antibacterial soaps, where it has banned 19 ingredients, the US Food and Drug Administration (FDA) has come out with an announcement on similar lines.
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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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May 15, 2015 Consumer Healthcare, Medical Devices, Regulatory LabelingPharmaceutical and medical device industries are constantly changing with developing supply chain themes and technological advancements due to which labeling must be looked upon with a new perspective. A host of latest trends have compelled Pharmaceutical and medical device industries to rethink, strategize and streamline processes, meet compliance norms and start and learn best practices.
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Ever since the eCTD submission became mandatory by FDA in 2008, the life sciences industry has been facing certain difficulties in regulatory processes. Even though the electronic common technical document has been of great help in managing huge volumes of important documentation; there are a few glitches that complicate the submission process for the organizations.
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April 2, 2015 Consumer Healthcare, Medical Devices, Pharmaceutical, Publishing & SubmissionsToday regulatory terms like eCTD, ASPPs, CANDA, SPL, MAA and NDA to name a few are the buzz words in the world of regulatory compliance. While each terminology indicates the inception of the cutting edge technology; they also come with some downright challenges for the life sciences companies.
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Good Laboratory Practices (GLP) covers the organizational process and conditions under which clinical field studies are conducted, monitored, recorded and reported. GLP is carried out to improve quality of data for its international acceptance.