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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.
Managing product information is quite a task. In the stringent world of life sciences, to do so, manufacturers must follow certain standards and procedures which are aligned to FDA’s regulations. Not only do they have to follow the set procedures but they are also required to maintain accuracy and integrity of information to be prescribed for an end-to-end compliance.
The artwork and labeling functions are under constant pressure when it comes to increasing demand towards reducing drug’s/device’s time-to-market. Besides time-bound pressures, the accuracy that needed to be aligned with health authority validation requirements challenge organizations’ compliant artwork pack management capabilities.
As the year-end is drawing nearby, it’s time to retrospect on all the Regulatory actions that the Pharma industry stood by to fall in compliance with Health Authority mandates. It is worthwhile to reflect upon the influential industry trends, HA guidance documents and major industry challenges that we’ve been covering in the last 12 months.
Is it the clinical pharmacology section of generic drugs and biologic’s labels requiring your attention? Are you chalking out a plan to gather the related data? Then it is the time you should know about Food and Drug Administration’s (FDA’s) finalized guidance on labeling. Here’s a quick overview.
What is Clinical Pharmacology?
If the latest government figures are any witness, the United Kingdom Life Sciences industry is a thriving £60 billion market, employing 220,000 people, and any potential threat to its growth is quite understandably worrisome.
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?
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.
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.
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