Free Newsletter
Register for our Free Newsletters
Newsletter
Zones
Access Control
LeftNav
Alarms
LeftNav
Biometrics
LeftNav
Detection
LeftNav
Deutsche Zone (German Zone)
LeftNav
Education, Training and Professional Services
LeftNav
Government Programmes
LeftNav
Guarding, Equipment and Enforcement
LeftNav
Industrial Computing Security
LeftNav
IT Security
LeftNav
Physical Security
LeftNav
Surveillance
LeftNav
View All
Other Carouselweb publications
Carousel Web
Defense File
New Materials
Pro Health Zone
Pro Manufacturing Zone
Pro Security Zone
Web Lec
 
ProSecurityZone Sponsor
 
ProSecurityZone Sponsor
 
ProSecurityZone Sponsor
 
ProSecurityZone Sponsor
 
ProSecurityZone Sponsor
 
ProSecurityZone Sponsor
 
 
News

Compliant submissions for pharmaceutical companiestest

Image Solutions : 29 October, 2008  (New Product)
ISI continues to evolve its electronic submissions service for the pharmaceutical industry to achieve compliance with European legislation
Image Solutions Europe has expanded its portfolio of services and outsourcing capabilities to help life sciences companies respond to the constantly evolving European standards around electronic submissions.

The European regulatory environment is complex and fast changing as the 27 countries that make up the European Union (EU) continually revise their approach to handling submissions. This evolving landscape was recently evidenced in the Czech Republic which originally mandated eCTD submissions from July 1st only to relax its guidelines in October accepting that the original mandate was impractical and leeway should be offered. All health authorities must be capable of receiving eCTD-only submissions by the end of 2009; however in the interim, pharmaceutical companies could be faced with creating different submission formats (eCTD, NEES, paper and sometimes in parallel) to meet the requirements of the EU member states.

"These are notoriously difficult waters to navigate and this has never been more true than now as drugs companies attempt to meet the requirements for electronic submissions from one country to the next," said Kate Wilber, Senior European Regulatory Specialist at ISI. "Keeping track of the European submissions landscape is a full-time job. Staying on top of how many paper copies are needed or whether a pure eCTD submission is now acceptable in each country is almost impossible, simply because the situation is continually being revised."

This increasing market interest in outsourcing of non-core activities stems from pharmaceutical organisations' attempts to sharpen their practices and reduce time to market given the darkening economic climate and rising competitive pressures. Strategically partnering with regulatory specialists ISI to partially or completely outsource submissions management processes and technology brings cost and time benefits derived from the superior economies of scale that ISI brings to the table. This is strengthened with faster time to market through rapid access to the right skills, adequate people resources, and the latest technologies coupled with extensive experience and an unrivalled reputation.

For pharmaceutical companies that don't have software in-house ISI offers fully outsourced publishing services and/or a Software as a Service (SaaS) alternative where the software and service is externally hosted and accessed on-demand leaving the pharmaceutical company to get back to its business. This is the option that global Pharma group Boehringer Ingelheim took with ISI last year investing in a SaaS delivery-based system, to help it meet an impending deadline for eCTD electronic submissions. FDA deadlines precluded using an in-house system (which would require extensive integration and the need for an entire team to be assembled to manage and support the technology). A further plus for Boehringer Ingelheim was that ISI offered it the flexibility to bring the technology in house if there came a point when this was deemed to be beneficial. The transition would be very simple, maintaining complete continuity of the systems being used, with any differences in output related purely to the change of location and ownership of the software and hardware. This offered Boehringer Ingelheim maximum flexibility.

"No single outsourcing blueprint will work for all companies or all types of submissions and at ISI we recognise that and offer a broad scope of services from consulting and partnering to partial or complete regulatory management outsourcing. That way, each company can select the level of service they need and 'pick and mix' accordingly," adds Kate. "We have clocked up many years of experience partnering with clients to deliver these services and we have an unrivalled team of specialists in Europe to call upon to help pharmaceutical companies address whatever eCTD challenges they face."
Bookmark and Share
 
Home I Editor's Blog I News by Zone I News by Date I News by Category I Special Reports I Directory I Events I Advertise I Submit Your News I About Us I Guides
 
   © 2012 ProSecurityZone.com
Netgains Logo