With years of time spent on innovating new drugs, life sciences organizations, sometimes, take a backseat to allocate sufficient time for artwork design processes that result in inaccurate and incompliant marketing of products followed by product recalls affecting the overall costs. With defined Regulatory artwork processes, organizations can sustain critical situations like these especially in time-bound pressures.
- February 10, 2017 Regulatory Artwork Services
- February 7, 2017 Pharmaceuticals, Regulatory Artwork Services
Even when artwork packaging is often considered to be a seemingly insignificant back office job, Artwork Pack Management is one of the key processes in the stringently regulated pharma world. For any given pharmaceutical or life sciences company, meeting the ever-changing regulatory-driven requirements of global markets and finding cost-effective ways to stick to compliance standards is a constant challenge.
- February 3, 2017 Publishing & Submissions, Health Authority Updates
What does it mean for Drug Approval Processes?
- January 31, 2017 Pharmaceuticals, Medical Devices, Regulatory Artwork Services
With years of efforts put into new drug, device and cosmetic products’ development, what can be every manufacturer’s nightmare would be to see their product recalled from the market for incompliant artwork issues. According to a study, it is estimated that 35 to 40% of product recalls are attributed to mislabeling and packaging errors.
- January 24, 2017 Regulatory Intelligence, Regulatory Consulting, Health Authority Updates
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.
- January 20, 2017 Regulatory Artwork Services, Regulatory Labeling
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. Even a single error might result in product recalls, fines and heavy cost burdens.
- January 17, 2017 Pharmaceuticals, Publishing & Submissions, Health Authority Updates
Life Sciences, as an industry is rapidly evolving, so does the Regulatory requirements to sustain in the industry.
- January 10, 2017 Pharmaceuticals, Publishing & Submissions, Health Authority Updates
The latest announcement from the Danish Medicine Agency (DMA) specifically points out elimination plan for NeeS format and emphasizes the consequent transition to eCTD for human domain / VNeeS for veterinary domain as directed in the eSubmission Roadmap.
Gear up to be Compliant
The future of Pharma Regulations has never been so complex and challenging and at the same time has never been so easy-to-deal with provided the burgeoning section of Regulatory Intelligence service providers feeding the industry with continuous health authority updates and requirements.
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.