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Creating compliant packaging for a cosmetic product is a collaborative effort of various departments in an organization such as: Labeling, Artwork and Regulatory Affairs. While label artwork must be validated by an artwork labeling team, it must combinedly be reviewed and approved by Regulatory Affairs team to ensure the compliance.
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Artwork services for the current Consumer Healthcare/Food Supplements landscapes are divided as per the markets. For Compliance based markets, artworks are created by Freyr team and submitted to the client for finalizing the artwork/ label.
The current medical device landscape has turned challenging for manufacturers in terms of ensuring quality and audit compliance due to ever-evolving regulations which may lead to extended time for approvals and market access.
The National Medical Products Administration (NMPA) of China recently released a comprehensive draft amendment for implementing the China Drug Administration Law (DAL).
After nearly two (02) decades of issuing the first draft guidance, the United States Food and Drug Administration (US FDA) finalized the guidance on population Pharmacokinetics (PK) in February 2022. The latest draft explains the application of population PK in drug development and recommendations on therapeutic individualization.
You might be aware, in the context of pending agreements between Switzerland and the EU, there are certain modifications/amendments made to the Medical Devices Ordinance (MedDO) and the Federal Council approved supplementary provisions for implementing medical device regulations, which are in force since May 26, 2021.
Isn’t it interesting to see Artificial Intelligence (AI) sculpting out to have a thriving position in the Regulatory landscape? One of the most important reasons for this advancement is the ability of AI and Machine Learning (ML) applications to tackle everyday procedural challenges and logical issues that compliance officers put up with.
The European Commission, along with the European Medicines Agency (EMA), released a notice to remind clinical trial sponsors to comply with the EU clinical trial rules following the Brexit transition period that is going to expire on 31 December, 2020.
Thanks to the evolving global Regulatory landscape! Each country now has its own, defined regulations and requirements in governing the quality, safety, and efficacy of the medicinal products entering or being manufactured in their market. In this scenario, it is necessary for organizations to know about specific Regulatory requirements of their targeted markets.
Artificial Intelligence (AI) is paving the way for innovative medicinal products and advanced medical devices. It is gradually headed towards decreasing repetitions in clinical trials, increasing the accuracy in drug designing processes and disease identification, personalization of patient diagnosis etc.
National Medical Products Administration (NMPA), formerly known as China Food and Drug Administration (CFDA), is all set to impose stricter regulations on auditing and reinforcement of clinical trials. To ensure best practices for in vitro diagnostic device (IVD), the agency released “Draft IVD Clinical Trial Guideline for Feedback” on November 22, 2018.
While researching for an innovative drug/device/cosmetic/food supplement, a huge amount of clinical data is expected to be generated. The conclusions of such data must be clearly reported with an appropriate level of detail to the health authorities (HAs). The information to be reported or documented might be research data, trial descriptions, findings, warnings etc.
Drug Information Association (DIA), a US-based non-profit, worldwide association, has unveiled its second annual report. The report offers industry experts’ detailed views on trends they anticipate in the world of medical product development for pharmaceuticals, biotechnology and medical devices in 2014. This year, three trends seem to be striving to take the top place.
North America
South America
East Europe
Europe
North Africa & Middle East
Southern Africa
APAC
Australia & New Zealand
Japan & South Korea
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