A new white paper from Europharm SMC, the industry association for small to medium-sized pharmaceutical companies across Europe, draws new attention to the plight of the smaller pharma organisation as eCTD submissions become the norm across Europe.
From an IT perspective, more modest-sized European pharmaceutical companies are faced with two major challenges, both of which require the allocation of a considerable amount of human, economical and technical resources, Europharm SMC notes. In addition to the implementation of the electronic common technical document (eCTD) standard, there is also the requirement for electronic reporting through the EudraVigilance system (a system for reporting and evaluating suspected adverse reactions during the development of medicinal products in the European Economic Area).
“Regardless of their size, small pharmaceutical companies face many of the same challenges as their larger counterparts when it comes to meeting new submissions requirements across Europe,” comments Adam Sherlock, MD of ISI Europe a specialist in electronic submissions solutions and services.
“2010 is the turning point when eCTD submissions and electronic information management have become the norm, rather than the exception. As a result, and much the same as their larger competitors have done in the past two years, many smaller firms are now playing catch-up as they try to match their capabilities to what are now industry requirements.”
To build up a picture of how its European companies are being affected, Europharm SMC conducted a survey among its SME members. Carried out late last year *, the poll found that while more than three-quarters of respondents had engaged in discussions with an eCTD software vendor about possible tools for managing submissions electronically, fewer than half of respondents (44%) had a system ready to go; 12% said they were outsourcing the activity to an external service provider.
Just over a quarter (28%) said they now had made new NP submissions in eCTD format; 12% had done this for MRP submissions, 24% for DCP submissions, and 0% for CP submissions. 12% had managed NP variations in this way; 16% MRP. This fell to 8% for NP renewals, and 12% for MRP renewals.
“The fact that more 75% of respondents are in discussions with an eCTD vendor is encouraging,” says Adam. “Most of those questioned expressed an interest in attending workshops on the subject, too, confirming that these companies are aware of what needs to be done and are taking the crucial first steps. Thankfully, there is a whole host of help available, for small organisations as well as larger players, not to mention a wide range of suitable solutions.”
At ISI, these include a series of consultancy, handholding, training and fully managed services, to help pharma firms navigate the eCTD maze quickly and efficiently.
“If organisations don’t have the time, budget or internal resources to deploy dedicated software internally, they can leverage ISI’s technical and regulatory expertise to host the software for them, or to manage any or all of the submissions activity for them,” Adam explains. “We specialise in helping pharma companies make the transition from paper-based submissions to electronic formats, so there is no need for them to go through this alone. Better still, by getting expert help, they can be assured of getting it right first time. Drawing on proven best practices offers them rapid, effective results, which is especially important now that time really is of the essence.”
About Europharm SMC
Europharm SMC (europharmsmc.org) provides specialized information & communication services to contribute to the competitiveness of small and medium-sized pharmaceutical companies within Europe.
About Image Solutions, Inc. (ISI)
Founded in 1992, Image Solutions, Inc (imagesolutions.com) is a proven market leader in providing submissions solutions, process services and consulting to Life Sciences companies as a way to improve clinical and regulatory processes that bring new medicines to market. ISI was among the first professional services firms to deliver electronic submissions to the industry and since has delivered thousands of electronic and eCTD submissions. ISI serves the top 50 pharmaceutical and biotech organisations as well as the top companies in other regulated industries.
ISI is a privately held company with headquarters in Whippany, New Jersey and operations throughout the U.S., Europe and Asia. ISI also remains committed to giving back to society and sharing its success with others by donating 10 percent of annual net profits to over 20 recognised charitable organisations.