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Health Canada eyes Plain Language Labeling

Health Canada eyes Plain Language Labeling for Safe Drug Labels

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In a recent study in Canada, it was observed, “1 in 9 emergency cases were related to drug adverse events, and as many as 68% of those were preventable”. Prevention is better than cure. Having learnt that, the first and foremost task for the companies is to look at the ways that prevent the adverse […]


Class II Device UDI Compliance: The challenges and the ultimate solution

Freyr IDENTITY, Regulatory Operations

September 24th 2016; with the deadline, just a month away for Class II device Unique Device Identifier (UDI) compliance, it is our assumption, if not for sure, that all medical device manufacturers are well equipped with a comprehensive Regulatory roadmap. Besides having a firm grip over governance pre-requisites, manufacturers are expected to be audit ready […]


New Labeling Requirements

New Labeling Requirements – The TGA way

Labeling, Regulatory Operations, Upcoming Mandates

What does it mean for Australian Medicine Labels? In a competitive world of life sciences, releasing a medicine (innovator/reference/generic) means the first step towards success for organizations. Having so much of significance inhered in, organizations must take care of the medicinal information they ought to provide through labels. The information provided on labels should not […]


GPvP compliance reports

MHRA no longer wants GPvP compliance reports to be submitted

Upcoming Mandates

Will it be a sigh of relief for drug makers? In a recent announcement pertaining to the Good Pharmacovigilance Practice (GPvP), the United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA) has updated that it no longer wants GPvP compliance reports to be submitted by organizations. With the update expected to drastically bring down the […]


Life Sciences organizations staffing balance

Should Life Sciences organizations be game for right staffing balance?

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. The involved costs, per say, could be of the Regulatory workforce, facilities, and other […]


eCTD Submissions in Multiple Geographies

The Ultimate Solution for eCTD Submissions in Multiple Geographies

Identify the best suited software ahead of time With an aim to grab the maximum market share, drug manufacturers (innovators/generics) may sometimes wish to market their products, across the globe, which have already got approvals in one region. However, following a single regulatory approach for all the regions is almost a difficult task and perhaps […]


successful GUDID submissions

Class II Device UDI Compliance

Regulatory Affairs

What it takes to achieve successful GUDID submissions? In our earlier article on Class II Device UDI Compliance,we have emphasized more on how to identify FDA UDI requirements pertaining to your specific products and data.Though it helps regulatory professionals draw up a comprehensive compliance plan,knowing the nitty-gritty of regulatory rules and procedures alone won’t help organizations […]


Brexit

The Brexit and the aftermath

Upcoming Mandates

The impact on Regulatory ecosystems in the UK and EU Is it the time to be alert for drug and medical device manufacturers associated with the European Union (EU) and the United Kingdom (UK)? As Britain voted to leave the EU, the situation seems to be uncertain for drug/pharmaceutical companies to plan ahead with the […]