Will you be ready and do you have the capability to reap the potential benefits as well as meet the authorities requirements?

Allow your organisation to reap the benefits of effective document management systems: we can work with you to implement solutions!

ePublishing

Competent Authorities increasingly require submissions to be made electronically, and an increasing number of European countries, strongly encourage electronic submission of marketing authorization applications.

In addition, all EU authorities will accept submissions in eCTD format from December 2009. ICH believe that the use of eCTD will make both the submission and review process more efficient, with resulting benefits to industry and the authorities.

♦ Unicus offers a truly comprehensive document management and electronic submissions service and has a long and successful track record in compiling and publishing multiple submissions across the EU.

Core competencies include:

♦ Our team is lead by a recognised expert with over 28 years experience in the regulatory field and 10 years experience in designing, validating and implementing effective document management systems.