In the first part of this series, we discussed what actually a medical writer does. In this segment, we will talk in detail about the process of medical writing.
- March 22, 2016 Regulatory Affairs, Regulatory Medical Writing
- March 16, 2016 Regulatory Affairs, Regulatory Medical Writing
The stringent regulatory guidelines, uncompromising regulatory spectrum and need of high-quality clinical documentation for submission to authorities have made the regulatory medical writers an important cog in the wheel for regulatory service providers and CROs.
- March 7, 2016 Publishing & Submissions
From 13 June, 2016 onwards
- March 2, 2016 Pharmaceuticals, Publishing & Submissions, Health Authority Updates
Enabling Multi-region submissions, effortlessly
- February 25, 2016 Pharmaceuticals, Regulatory Artwork Services, Health Authority Updates
Under the scope of meeting the new Falsified Medicines Directive requirements, the EMA and EC have come up with an implementation plan which introduced two new safety features to be added on the packaging of drugs by 9 February 2019.
- February 18, 2016 Pharmaceuticals, Health Authority Updates
The US FDA’s proposed rule on Generic Drug Labeling: Explained
- February 9, 2016 Pharmaceuticals, Publishing & Submissions, Health Authority Updates
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 DMF submission partner?
- January 25, 2016 Pharmaceuticals, Regulatory Labeling, Health Authority Updates
In our last blog we talked about a Major Generic Drug Labeling Rule that will entail new guidelines for updating labels of generic drugs in terms of safety information. In this segment we are emphasizing on getaways from the guidance proposed by FDA with respect to safety assessment for IND Safety reporting.
- January 21, 2016 Regulatory Artwork Services, Regulatory Labeling
Artwork and labeling development in the pharma industry involves several groups across the organization, handling these processes but in most cases external service providers support companies to streamline the entire pharmaceutical labeling and artwork lifecycle.
- December 22, 2015 Regulatory Labeling, Health Authority Updates
Recently FDA has confirmed announcement of a major and final rule of labeling coming in July 2016 that will entail new guidelines for updating labels of generic drugs in terms of safety information. Announcing this final rule, FDA intends to make the process of label update easier for generic drug companies.
Influence of Present Rule