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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 US is the largest medical device market, worth USD 180 billion (2021) and is expected to reach USD 670 billion at a CAGR of 5.2% from 2022 to 2027. The global medical device manufacturers find it promising to get their devices approved by US FDA and subsequently export them to the US.
When the COVID-19 pandemic was first recognized as a global health crisis in 2020, global Health Authorities (HAs) took innovative steps to deal with it in the best possible manner. Likewise, pharmaceutical companies came up with several vaccines/medicinal products for the benefit of the public. However, registering the products turned out to be quite challenging.
Do you know? One can save up to a million in the coming three (03) years by introducing Computer Software Assurance (CSA) in place of the existing Computer system validation (CSV) model!
Over the years, pharmaceutical organizations have incorporated CSV, a risk-based validation approach to ensure computer operating systems are at par with Regulatory requirements.
FSSAI published a major update on the Front Pack of Labelling (FOPL) on 22nd February 2022 after a meeting with the stakeholders, to decide the remaining issues related to ‘Front of Pack Labelling’ under the Chairmanship of CEO, FSSAI. The FSSAI commenced the meeting with a presentation on the development journey of FOPL in India and the decisions taken in the last meetings.
Brazil is the largest cosmetic market in the Latin American region. Increasing consumer awareness and a rising disposable income ensure steady market growth. Major international cosmetic brands also have a presence in this attractive market.
With the advent of digitization, many global organizations, especially in life sciences and med-tech industries, have randomly shifted their data from paper to digital forms. Thanks to the stringent regulations, like US FDA’s 21 CFR Part 11 (21 CFR 11) regulation, the digitalized data forms are coming out to be accurate, efficient, productive, quality-oriented and reliable.
We all are aware of how food and medicine are different in terms of how they individually nourish the body, but both eventually tend to mainly assist in maintaining our health.
The medical devices industry is considered as highly regulated. Hence, devising a right Regulatory strategy will be a potential approach and a great value-added contribution to avoid Regulatory roadblocks.
Clinical and nonclinical research programs demand the development of high-quality documents for timely submissions and approval of the drug product from Regulatory authorities. Medical writing plays a crucial role in drafting all the necessary documents right from drug development through submission and approval.
The MDCG (Medical Device Coordination Group) has released a position paper on UDI assignment to assist the manufacturers of spectacle lenses and ready readers about the obligations under the EU Medical Device Regulations (EU MDR) 2017/745. It also has the details to be considered while assigning an UDI (Unique Device Identification) to these devices.
North America
South America
East Europe
Europe
North Africa & Middle East
Southern Africa
APAC
Australia & New Zealand
Japan & South Korea
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