When it comes to dossier submissions for medicine registrations, each country has its own Regulatory data requirements which should be submitted in set formats and templates. Likewise, dossier submissions towards South African market has specific format to be considered. Regulating complementary medicines in South Africa post June 2016 requires dossier submissions in ZA CTD (South Africa Common Technical Document) format…
- November 15, 2016 Pharmaceuticals, Publishing & Submissions, Health Authority Updates
- November 3, 2016 Regulatory Labeling, Freyr Announcements
Now that we have decoded various Regulatory Labeling challenges from different perspectives, is it the time you think to scout for a comprehensive Regulatory Framework? The answer would be a sure shot yes leading to search for innovative products, technologies, solutions, and services the industry is offering.
- October 27, 2016 Pharmaceuticals, Health Authority Updates
Do you remember? A couple of days back we discussed the Food and Drug Administration’s (FDA) final safety rule for antibacterial soaps. Following the US FDA’s call for the ban on specific ingredients, Japan turns the first implementation force in APAC announcing that they have implemented the ingredient ban already.
- October 18, 2016 Pharmaceuticals, Regulatory Intelligence, Regulatory Labeling, Regulatory Consulting
In an ever changing Regulatory environment, health authorities around the world mandate drug companies with various drug labeling formats and standards. To comply with those time-critical labeling mandates, organizations find it challenging to create, track and manage various aspects of drug labeling lifecycle.
- September 29, 2016 Pharmaceuticals, Regulatory Labeling
The accelerated introduction of new regulations and guidelines for pharmaceutical labeling industry during past few decades, demands companies to be pro-active in terms of the implementation lifecycles. The dire consequences associated with the erroneous label on a drug or a medical device accounts to severe health risks for the patients.
- September 28, 2016 Compliance, Audit and Validation, Regulatory Affairs, Health Authority Updates
The key to achieve Excellence in Pharma
- September 22, 2016 Medical Devices, Regulatory Affairs, Regulatory Intelligence, Health Authority Updates
The influence on Medical Device’s Regulatory Decision Making
- 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?