The influence on Medical Device’s Regulatory Decision Making
- September 22, 2016 Medical Devices, Regulatory Affairs, Regulatory Intelligence, Health Authority Updates
- September 20, 2016 Consumer Healthcare, Cosmetics Regulatory Services, Regulatory Affairs, Health Authority Updates
In 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.
- September 6, 2016 Cosmetics Regulatory Services, Health Authority Updates
The cosmetic notification system in Malaysia has been active for quite some time now. It has given cosmetic manufacturing companies from all over the world a fair opportunity to have their products distributed in the emerging market of Malaysia. Having said that, our question is, have you notified your products in the market?
- August 30, 2016 Pharmaceuticals, Regulatory Labeling, Health Authority Updates
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 events?
- August 23, 2016 Medical Devices, Compliance, Audit and Validation, Health Authority Updates
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 for the compliance.
- August 11, 2016 Regulatory Labeling, Health Authority Updates
What does it mean for Australian Medicine Labels?
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.
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.
- July 20, 2016 Pharmaceuticals, Publishing & Submissions, Health Authority Updates
Do 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.
- July 19, 2016 Pharmaceuticals, Publishing & Submissions, Regulatory Consulting
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 not advisable.