As with most compliance solutions, companies will put whatever is needed in place to meet the requirements, and come back and re-evaluate their decisions later. On January 1, 2008 the FDA withdrew guidance for non-electronic common technical document (eCTD) submissions, and to prepare for that, along with various other regional requirements, pharmaceutical companies implemented multiple solutions to address their varying requirements.

A year ago organizations were talking to us about preparing electronic submissions, and seeking the assistance of the technology vendors to help them get organized for this upcoming event. Although some had already chosen a tool, some were still looking, and most were still trying to find out more about what was available, whether they had purchased a tool or not.

It is over a year later, and the mood is different. I talked to a number of companies at DIA this week that are looking to standardize on an eCTD submissions tool. The problem, they explained to me, is that they cannot get it all from a single tool. They know what the need to do, and now they want to do it.

But this market is maturing from a technology adoption perspective; it is no longer the early adopter market that it once was. It is mainstream -- the early majority, according to Geoffrey Moore's Crossing the Chasm. This is the time when the superior products will rise to the top, and others will struggle and drop-out of the market.

Pharmaceutical companies can expect to get what they require, without have to use multiple technologies for varying requirements. It will be interesting to see how things change over the next year.

Resources:
Podcast - Electronic Submissions - Pharmaceutical and Life Sciences Industry