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 20, 2017 Regulatory Artwork Services, Regulatory Labeling
- 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.
Regulatory Guidelines for the Pharma Industry, so far in ‘16
In an ever changing world of Life Sciences regulations, the Pharma industry has seen many new mandatory requirements from the health authorities worldwide.
- December 15, 2016 Regulatory Artwork Services, Regulatory Labeling, Health Authority Updates
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?
- November 30, 2016 Publishing & Submissions, Health Authority Updates
Are you planning for clinical or non-clinical studies post December 17, 2016? If yes, we suggest you take a look at Food and Drug Administration’s (FDA’s) study Data standards applicable for certain types of submissions to CDER and CBER.
- November 23, 2016 Publishing & Submissions, Health Authority Updates
In the October released guidance, Medicines Control Council (MCC) has given clarity for manufacturers who are willing to submit applications for medicine registrations in electronic common technical document (eCTD) format. The guidance mainly emphasized the implementation timelines of South African Module 1 eCTD Specification…
- November 17, 2016 Regulatory Artwork Services, Regulatory Labeling, Health Authority Updates
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.