A Case Study in eSubmissions
FDA’s announcement in December 2007 that it would only accept electronic regulatory submissions in eCTD format starting January 1st was no cause for concern for Boehringer Ingelheim. That’s because by then the Ingelheim, Germany based pharmaceutical company could compile a compliant eCTD (electronic common technical document) submission. Read More

Picking Up the Pace
The way organizations buy and manage their software has changed significantly in recent years, as firms have begun to take advantage of ubiquitous high-speed network connections to let external software experts host and maintain their IT resources remotely. Read More

Submission Tactics
With the burden of bringing a product to market becoming more difficult due to stricter regulatory demands, increased competition, tighter pipelines, and a risk-averse public, many pharmaceutical and biotech companies have begun to recognize that there is need for greater business process efficiencies. Read More

Small Biotech Companies Handle Most Regulatory Filings on Paper, Study Shows
Most small and mid-size biopharmaceutical companies still handle most regulatory filings on paper, recent industry research shows, despite the fact that larger companies and regulators are rapidly shifting toward an electronic environment. Executives at many of these companies, however, are seeking electronic options that can be implemented quickly and cost-effectively, but which also can be scaled up as the company grows and submits regulatory filings in more regions of the world. Read More

Electronic submission standards: Opening the door to change
As the pharmaceutical industry embraces the Electronic Common Technical Document (eCTD) standard for drug licence submissions, companies with foresight are seizing this as an opportunity to streamline their internal submissions-related processes to achieve multiple gains. Read More

Opening the Door to Change
According to Peter Reynolds, of Image Solutions Inc, remotely hosted submission software and services could be the key to the dynamism and agility pharmaceutical companies now crave. Read More

ISI Expands eCTD Options for Small and Mid-size Players. Ready or not, here it comes. The eCTD deadline, that is.
Many large pharmaceutical companies are sitting pretty as the January 1, 2008, deadline approaches for required use of the electronic common technical document (eCTD) for electronic submissions to FDA. But the rest of the market -- small to mid-size players -- is in a very different place. Read More

E-solutions in Clinical Trials: Digital Dilemma
With e-solutions poised to rule the future of drug development, pursuing these measures is no longer a luxury for the pharmaceutical industry but a necessity, making the adoption and maintenance of new informatics more critical than ever. Read More

It’s ‘go time’ for the Pharmaceutical Industry
Now more than ever, the strategic use of IT combined with operational excellence — integrated, streamlined and harmonized processes in an electronic work environment – becomes critical to a pharmaceutical company’s success as well as the way to get the industry to an entirely new business model. As companies rethink these models, many are adopting unconventional approaches to leveraging IT. Read More

Making the move to electronic submissions: considerations before jumping.
Many of the most complex and risk-laden areas in the drug development lifecycle can be ound at the regulatory submission stage. One misstep and approvals are held back for months, if not years. Peter Reynolds looks at ways of navigating these treacherous waters.  Read More

Templates: Taking the first step towards eCTD submissions in Europe.
The Common Technical Document (CTD) has been the mandatory marketing application format for submissions in the European Union (EU) since 2003.  Read More