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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. Highlighting the major breakthroughs, here we give you a relook at top 20 topics we’ve covered in 2016 including submission and labeling mandates, the Brexit and the aftermath, mandates and amendments, and some of the opinions.
Outsource Artwork & Labeling – Make Your Decision Now!!!
Why should Companies give up Paper DMF Submissions?
Will it be the end of dependency for generic drug manufacturers?
9 Feb, 2019: Deadline for new packaging features introduced by EU.
PSUR Submissions to be directed towards central repository at EMA
Medical Writers Part 1: Driving Effective Regulatory Documentation
Medical Writers Part 2: How to Handle Draft Preparation and Internal Review
UAE to implement the eCTD for Streamlined Pharmaceutical Products’ Registration
eCTD Module 1 V3.0 for EU – What should companies know about the revised specification?
Cosmetics Compliance and the upcoming Global Regulatory Scenarios
The Ultimate Solution for eCTD Submissions in Multiple Geographies
Should Life Sciences organizations be game for right staffing balance?
New Labeling Requirements – The TGA way
Health Canada eyes Plain Language Labeling for Safe Drug Labels
CDRH’s Top 10 Regulatory Science Priorities for FY 2017
Global Labeling Management Roadblocks Disquieting the Efficiency of Pharma Companies
Regulatory Labeling Challenges and Freyr’s Path breaking GLX Framework
The importance of ZA CTD for South African Drug Registrations
Health Functional Food – Get an Overview at this Live Webinar
We hope this relook will help you reexamine the Regulatory actions in the past year and realign with that of the upcoming one. Wishing you a great holiday season ahead, we thank you for reading!
