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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.
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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.
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.
It’s an industry-known fact that the European Chemical Agency (ECHA) has continuously been on researching about the alternative methods that have been used to generate information on the intrinsic properties of chemical substances and for risk assessment. Following the previous three reports, the Agency has now published its fourth report based on registration datasets obtained in 2016 and...
Industries across the world are evolving in terms of innovation, and it is no different for the food supplements industry. The food and food supplements industry is booming and majority of its credit goes to the innovative products that are being introduced in the global markets. In most of the cases, new products are manufactured with the help of novel ingredients known as ‘New Dietary...
Reducing the complexity of Regulatory submissions, the global Regulatory Authorities transformed all the submissions from paper to electronic format. Respectively, there are several electronic submission formats proposed by country-specific Regulatory bodies.
Recently, the US FDA issued a new guidance for electronic submission for medical devices, following a draft...
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. As there is no possibility for further extension of Brexit transition period, the EC has released Brexit readiness notice...
Considering the severity of the on-going Covid-19 global pandemic, Health Canada (HC) is consistently warning hand sanitizer manufacturers about the use of the right formulation and ingredients in their products. Recently, the Agency halted 12 hand sanitizer companies from selling their unsanctioned products in the Canada due to the presence of unapproved ingredients. The step was taken by the...
Amidst the Covid-19 pandemic, the demand for surgical apparel (including gowns, gloves, togas and other apparel) has increased drastically. But on the other side, supply chains are going down with minimal production. Therefore, to increase the availability of these products in need, the United States Food and Drugs Administration (US FDA) has released a guidance document addressing urgent...
With an aim to make anonymized clinical information in drug submissions and medical devices applications publicly accessible, Health Canada released a guidance document named as Health Canada's Public Release of Clinical Information (PRCI). Adhering to Canada’s Privacy Act, this document on clinical information enables independent re-analyses of data, completion of Health Canada’s Regulatory...
As we look at these challenging times for manufacturers across the life sciences industry, of course, not in terms of manufacturing products, but to market them across the globe compliantly, we understand there is a dire need for effective Regulatory solutions and services to ensure products compliant market entry. As always, we believe that they need a dedicated approach and a clear-cut...
With the continual rise of COVID-19 cases, the healthcare facilities are witnessing shortage of respirators. Assessing the critical shortage and enormous demand for respirators, the global Regulatory agencies are swiftly initiating significant efforts to develop practical methods for decontaminating used respirators effectively. Accordingly, Singapore’s Health Sciences Authority (HSA) has...
The use of face masks is increasing due to the rapid spread of COVID-19. To meet the growing demand, different types of face masks are manufactured and released into the market, claiming to serve the medical purpose. To be precise, the European Commission (EC) has clearly defined the medical face masks and proposed Regulatory options to place them in the EU market with short-term supply...
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