The Impact of Artificial Intelligence on Regulatory Affairs
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Understanding the Importance of Pharmacovigilance in Patient Safety
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Embracing RegTech: The Future of Regulatory Compliance in the Pharmaceutical Industry
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Streamlining Success: The Impact of Regulatory Outsourcing in Pharma Workflow
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Charting Regulatory Pathways: The Transformative Journey of the Cosmetics and Aesthetics Industry in Healthcare
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The Crucial Intersection: Intellectual Property Rights & Regulatory Affairs in the Pharmaceutical Industry
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The Vital Role of Regulatory Affairs in Pharmaceutical Manufacturing
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Pharmacovigilance GCC Certification
Our client was a manufacturer of medical devices from the UK. They had a unique requirement for a single product category to add storage conditions to the product labelling of their contact lens product in one specific geographic region.
The Problem
The labelling requirement was only for contact lenses sold into the United Arab Emirates. It would have been simple enough to create a new label and have this approved, but the client was unwilling to go through the trouble and cost of having their global label changed in any way since it was already registered and approved worldwide.
Another problem was that the regulators would not accept a sticker to be placed on the outer package, adding storage conditions to the packaging.
To summarize the challenge, we needed to add storage conditions to the packaging on products destined for the UAE market.
- Published in courses