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Regulatory Rules, Opinions & Thoughts
FDA adds technical rejection criteria for existing eCTD validation

FDA adds technical rejection criteria for existing eCTD validation. What should you know?

Regulatory Operations, Submissions & Publishing

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. Beginning December 17, 2016, be it new drug applications (NDAs), biological license applications (BLAs) or abbreviated […]


MCC timelines for medicine registrations in eCTD V2.0

MCC timelines for medicine registrations in eCTD V2.0. What should you know?

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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 and Validation Criteria v2.0. Having given clarity on the implementation timelines, […]


Brexit and its Possible Impact on the UK Life Sciences Industry

Brexit and its Possible Impact on the UK Life Sciences Industry

Upcoming Mandates

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. So, even when BREXIT (Britain’s exit from the EU) is at least two long years away, the current atmosphere is marked […]


ZA CTD for South African Drug Registrations

The importance of ZA CTD for South African Drug Registrations

eCTD, Regulatory Operations

When it comes to dossier submissions for medicine registrations, each country has its own Regulatory data requirements which should be submitted in set formats and templates. Likewise, dossier submissions towards South African market has specific format to be considered. Regulating complementary medicines in South Africa post June 2016 requires dossier submissions in ZA CTD (South […]


Regulatory Labeling Challenges

Regulatory Labeling Challenges and Freyr’s Path breaking GLX Framework

Labeling, Regulatory Operations

Now that we have decoded various Regulatory Labeling challenges from different perspectives, is it the time you think to scout for a comprehensive Regulatory Framework? The answer would be a sure shot yes leading to search for innovative products, technologies, solutions, and services the industry is offering. How about choosing an award winning Regulatory Labeling […]


Japan Ingredients Ban

Japan Implements the Ingredient Ban for Medicated Products

Upcoming Mandates

Do you remember? A couple of days back we discussed the Food and Drug Administration’s (FDA) final safety rule for antibacterial soaps. Following the US FDA’s call for the ban on specific ingredients, Japan turns the first implementation force in APAC announcing that they have implemented the ingredient ban already. In an announcement, the Japanese […]


Regulatory Labeling and the Industry Challenges

Regulatory Labeling and the Industry Challenges

Labeling, Regulatory Operations

In an ever changing Regulatory environment, health authorities around the world mandate drug companies with various drug labeling formats and standards. To comply with those time-critical labeling mandates, organizations find it challenging to create, track and manage various aspects of drug labeling lifecycle. Right from managing various activities involved in the labeling process like review […]


Global Labeling Management

Global Labeling Management Roadblocks Disquieting the Efficiency of Pharma Companies

Labeling, Regulatory Operations

The accelerated introduction of new regulations and guidelines for pharmaceutical labeling industry during past few decades, demands companies to be pro-active in terms of the implementation lifecycles. The dire consequences associated with the erroneous label on a drug or a medical device accounts to severe health risks for the patients. Physicians rely on the label […]


Streamlined Regulatory Procedures for Successful Compliance

Streamlined Regulatory Procedures for Successful Compliance

Regulatory Affairs, Upcoming Mandates

The key to achieve Excellence in Pharma In an endeavor to reach the end user within the shortest timelines, drug manufacturers / organizations sometimes might miss out certain must-to-follow Regulatory procedures, thus hindering the Compliance efforts, required product registrations and market authorizations. In addition, using legacy applications and systems add-on to the worries of incompatibility, […]


CDRH’s Top 10 Regulatory Science Priorities

CDRH’s Top 10 Regulatory Science Priorities for FY 2017

Upcoming Mandates

The influence on Medical Device’s Regulatory Decision Making Centre for Devices and Radiological Health (CDRH), a division of US Food and Drug Administration (FDA) seems to be all set to enhance the quality of Medical Devices and Radiation-emitting products in order to ensure the patient safety. Emphasizing the same, Regulatory science at CDRH has released […]