1. INTRODUCTIONThe pharmaceutical quality control laboratory serves one of the most important functions in pharmaceutical production and control. A significant portion of the CGMP regu… Read More

What’s driving drug shortages during the cold and flu season? When shock events impact the medicines supply chain, underlying vulnerabilities can cause it to break instea… Read More

Supply chain vulnerabilities exist for antimicrobial medicines: USP Medicine Supply Map analysis Antimicrobial resistance (AMR) is named one of the top 10 global health threats… Read More

Decode the Health Canada, and US FDA new DMF Submission Mandates Are you a DMF holder willing to submit your paper Drug Master Files (DMFs) to Health Canada? Or are you looking for a paper D… Read More

Ahead of nearing mandatory eCTD deadline, 5/5/2017, to clear the confusion surrounded, the Food and Drug Administration (FDA) of United States has clarified what exactly it is looking for in… Read More

FDA published a guidance in May 2015 announcing a deadline for electronic submission of active DMFs.  As per these guidelines, DMF holders are required to submit the baseline submission… Read More

Enabling Multi-region submissions, effortlessly While concluding our recent blog post on the Health Canada and the FDA’s DMF Submission mandates, we’ve realized how difficult and… Read More

Today & Tomorrow Walkins Jobs in Ankleshwar for Experienced Job ID : 20170810012 Company : Cadila Healthcare Limited Job Role : Quality Control & Quality Assurance Eligibility : M… Read More

As said and done for many times till now, the United Sates Food and Drug Administration (USFDA) has set a compliance deadline for eCTD (electronic common technical document) submissions. The… Read More