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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.
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.
To ensure that cosmetics align with the latest quality and safety standards, markets across the globe have stringent Regulatory requirements. In markets such as the European Union, the United Kingdom, Malaysia, India, Saudi Arabia, etc., appointing a Legal Representative/Responsible Person (RP)/ Local Agent/License Holder is mandatory for local compliance.
Applicants often misunderstand the scope of the meetings with the Medicines and Healthcare products Regulatory Agency (MHRA) and fail to comply with the legislative requirements of such meetings. These misunderstandings create prejudice against the procedure and affect the success rate of the meetings.
Scientific advice meetings with the MHRA can be held in the following phases.
The life sciences industry is ever-changing and evolving. It’s the same in the year 2018. A lot of mandatory changes have been made to the regulations, and a lot of guidance documents have been released pertaining to the best Regulatory practices of consumer healthcare, medical devices, pharmaceuticals, which are expected to impact the industry in a positive way.
The year 2017 was an eventful year for the Regulatory space, with several major happenings taking place across various industries such as: Pharmaceuticals, Biologics, Cosmetics, Medical Devices (MD) etc. While the MD industry witnessed the strengthening of MD regulations across the EU, the cosmetics industry saw advancements in the form of improved guidelines for cosmetic product safety.
Mexican Medical Device market is expected to reach $6.5 billion by 2020. Being the second largest market for medical devices in Latin America, Mexico offers a good bet of business opportunities.
The upsurge of economic and industrial developments across the Middle East and North Africa has established the MENA region as a dynamic life sciences and healthcare market. As per reports, consistently growing affluence in the Gulf Cooperation Council (GCC) countries has led to many lifestyle changes resulting in steep rise in total healthcare expenditures.
Wading through uncharted waters is always risky and mount numerous pressures on organizations. It not only affects organization’s financial status quo but also impose threat to brand image. If it is the same in the life sciences sector, the situation may lead to incompliance and untimely drug approvals thus posing a threat to patient safety.
In a recent announcement, the US Food and Drug Administration (FDA) asserted the ban on powdered medical gloves will come into effect, beginning 19 January 2017.
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.
North Africa & Middle East
Australia & New Zealand
Japan & South Korea
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