Ever since the inherent risk in the marketing of medical devices and drugs increased, establishment of a tailor-made regulatory strategy for business success has been the call of the hour. The global environment has become pervasive because of the growing complexity in the pharmaceutical devices. Ultimately the regulation and market adoption of those avant garde drug/devices have adopted the same speed.…
- April 9, 2015 Pharmaceuticals, Regulatory Consulting
Ever since the eCTD submission became mandatory by FDA in 2008, the life sciences industry has been facing certain difficulties in regulatory processes. Even though the electronic common technical document has been of great help in managing huge volumes of important documentation; there are a few glitches that complicate the submission process for the organizations.
- April 2, 2015 Pharmaceuticals, Regulatory Affairs, Regulatory Consulting
It’s no strange for everyone who is into regulatory intelligence services that a well-proportioned regulatory strategy plays a key role in boosting the opportunity of regulatory approval. Now a regulatory plan is also equally important which helps in meeting the objectives of the regulatory approval process.
- April 2, 2015 Pharmaceuticals, Medical Devices, Consumer Healthcare, Publishing & Submissions
Today regulatory terms like eCTD, ASPPs, CANDA, SPL, MAA and NDA to name a few are the buzz words in the world of regulatory compliance. While each terminology indicates the inception of the cutting edge technology; they also come with some downright challenges for the life sciences companies.
- March 17, 2015 Regulatory Affairs
Emerging markets in Asia Pacific, Latin America and Eastern Europe are increasingly important locations for drug development as sponsors pursue multinational programs to gain access to appropriate patient populations. And regulatory intelligence plays a crucial role in drug development and regulatory strategy.
- March 10, 2015 Pharmacovigilance, Regulatory Affairs
Why a Company Core Data Sheet (CCDS) is required and what is its significance for the marketing authorization holders (MAH).
- March 4, 2015 Regulatory Affairs
It is tough for Pharma companies to be cognizant of all existing global regulatory requirements owing to the ever changing worldwide regulations and legislations. New procedures are always being developed and adopted by regulatory authorities worldwide due to the international harmonization process.
HISTORY OF REGULATORY INTELLIGENCE (RI)
- December 11, 2014 Publishing & Submissions, Health Authority Updates
Back in 2012 an ordinance was passed under which all the drug applications to the Saudi Food and Drug Administration (SFDA) were required to be processed through the electronic common technical document (eCTD). It was only till Jan. 3, 2015 that the non-eCTD electronic submission including NeeS format were allowed, and thereafter it was mandatory for SFDA to accept electronic CTDs.
- December 11, 2014 Regulatory Affairs
Most of the life sciences companies now face increasing consumer, portfolio, regulatory and operating challenges on a daily basis as they carry on their search for innovative health solutions. In order to create and sustain competitive differentiation and market dominance, the life sciences sector must meet the diverse challenges of your regulatory/life cycle strategy today while supporting innovations of tomorrow.
- December 11, 2014 Regulatory Affairs
AN OVERVIEW