Tackle Issues of Quality Control In the Contract’s Operations Section
The operations portion of the supplier quality agreement deals with quality control issues that will be ongoing during a drug’s production.
Administrative Section: ‘Nuts and Bolts’ of the Supplier Quality Agreement
Companies need to consider all aspects of their relationship with prospective suppliers that could put them at risk for noncompliance with the FDA or increase the likelihood a poor quality…
From IND to eCTD: Process Allows Data to Be Submitted as It’s Collected
Despite having an extra year before they must start submitting IND applications electronically to the FDA, companies should convert their IND process before NDAs and BLAs, in order to gain…
Creating an Internal Framework for Application eSubmission
If sponsors expect to be ready to begin electronically submitting all applications by 2017, they must first build a framework for handling and retrieving documents and data in electronic form,…
Countdown to 2017: Start Early to Build an FDA-Compliant eCTD System
Beginning in fiscal year 2017, drug and biologics makers must be ready to submit to the FDA in electronic form all documents related to new drug applications (NDA), biologics license…
Abstract
The FDA will soon require drug and biologics makers to submit all new product applications in an electronic format. And within a few short years, the agency will stop accepting…
Ten Steps to Effective eCTDs Each and Every Time
Companies want to develop the most effective electronic system possible to ensure efficient and reliable submission and acceptance of eCTDs.
Challenges of the eCTD Process Include Document Authoring, Granularity
Many companies that submit improper eCTDs either failed to learn the intricacies of what goes into a validated eCTD or didn’t adopt the necessary process changes.
PDF Files Must Comply with FDA Guidance or Risk Being Rejected
When preparing documents for an eCTD submission, sponsors must ensure that all materials are properly formatted so that the review can start on time and proceed smoothly.