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Freyr Regulatory Compliance Blog


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Freyr Blog is a Regulatory Compliance blog which talks about regulatory affairs, regulatory operations global regulatory solutions.
TGA Label Changes. Decode The Updates.
2017-08-01 16:05
It’s been almost a year since we’ve reported that Therapeutic Goods Administration (TGA) is on its way to impose new labeling requirements. Been effective from 31st Aug 2016, the… Read More
EMA, SPOR, IDMP, And The Story Behind
2017-07-04 13:05
In its latest announcement, European Medicines Agency (EMA) informed the Industry Change Liaisons that it has formally approved P&SMS Iteration 1 project covering Identification of Medic… Read More
EU MDR – Prepare For 2020 DL
2017-06-29 13:44
The regulations of the medical device industry in Europe may have remained relatively unchanged since the 1990s but recent upheavals such as the breast implant crisis and hip replacements re… Read More
EU To Strengthen Medical Device Regulations
2017-05-04 13:45
With over 5,00,000 types of Medical Devices (MDs) and in-vitro diagnostics (IVDs) existing, the European MD and IVD market stands as a major economic player. On the other side, recent scanda… Read More
Medical Writing Vs Science Writing
2017-03-14 14:08
Medical Writing industry is on an upward surge, mainly driven by an increasing demand in Emerging markets to have high-quality documents authored to support timely drug approvals. At the fac… Read More
The Importance Of Regulatory Intelligence
2017-03-02 13:40
Wading through uncharted waters is always risky and mount numerous pressures on organizations. It not only affects organization’s financial status quo but also impose threat to brand i… Read More
2017 And Farther
2017-01-03 12:13
Gear up to be Compliant The future of Pharma Regulations has never been so complex and challenging and at the same time has never been so easy-to-deal with provided the burgeoning section of… Read More
Top Blogs 2016 – Relook And Realign
2016-12-27 13:29
As the year-end is drawing nearby, it’s time to retrospect on all the Regulatory actions that the Pharma industry stood by to fall in compliance with Health Authority mandates. It is w… Read More
Throwback 2016
2016-12-22 12:13
Regulatory Guidelines for the Pharma Industry, so far in ‘16 In an ever changing world of Life Sciences regulations, the Pharma industry has seen many new mandatory requirements from… Read More
New Labeling Requirements – The TGA Way
2016-08-11 14:22
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 organiz… Read More
Class II Device UDI Compliance
2016-07-07 14:10
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… Read More
The Brexit And The Aftermath
2016-06-30 14:46
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)?… Read More
2016-03-02 13:42
Enabling Multi-region submissions, effortlessly While concluding our recent blog post on the Health Canada and the FDA’s DMF Submission mandates, we’ve realized how difficult and… Read More

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