13
Oct 2015

Four Reasons Drugs are Expensive – Of Which Two are False

From Matthew Harper at Forbes.
Read more...

Source: Forbes

03
Aug 2015

Thai eCTD FAQ - In 2017 eCTD submission will be mandate for all submission

eCTD Submission will be mandate for New Chemical Entity, New Drug, New Biological, Biological and optional for Generic and New Generic in 2016. In 2017 eCTD submission will be mandate for all submission.

Thai eCTD FAQ- Read more...

Source: FDA

10
May 2015

eCTD Technical Conformance Guide

FDA has published a Technical Specification Document, eCTD TECHNICAL CONFORMANCE GUIDE on its eCTD Web Page (added on 10/05/2015). This is the Initial Version and supplements the guidance for industry Providing Regulatory Submissions in Electronic Format — Certain Human Pharmaceutical Product Applications and Related Submissions Using the eCTD Specifications (eCTD Guidance).

This eCTD Technical Conformance Guide provides specifications, recommendations, and general considerations on how to submit electronic Common Technical Document (eCTD)-based electronic submissions to the Center for Drug Evaluation and Research (CDER) or the Center for Biologics Evaluation and Research (CBER).

This Guide should be considered a companion document to the following:
Guidance to Industry Providing Regulatory Submissions in Electronic Format — Certain Human Pharmaceutical Product Applications and Related Submissions Using the eCTD Specifications
FDA eCTD Web page
FDA Data Standards Catalog

Read more....

Source: FDA

02
Nov2016

BioVectra chooses pharmaREADY for eCTD Solution

BioVectra has chosen pharmaREADY for its eCTD requirements. BioVectra, located in Canada, manufactures ingredients for global...

05
Oct2016

Navitas at DIA's 10th Annual Forum for Qualified Persons...

Navitas Principal Jeffrey Ho will present “Efficient content management for the compilation and management of the...

12
Jul2016

Navitas Celebrates 100th pharmaREADY customer

pharmaREADY is Navitas’ intuitive and easy to use, fully integrated, regulatory compliant, web-based suite comprised of modules...

16
Oct2015

Navitas Introduces Innovative Regulatory Process Outsourcing Model

The workload for regulatory functions of pharmaceutical companies has continued to increase in recent years ...