MISSION STATEMENT

Providing scientific and regulatory consultant services

to the global pharmaceutical,

dietary supplements and medical devices

and diagnostic products industries

Electronic Submission

ANNOUNCING A NEW SERVICE …

FDA ELECTRONIC SUBMISSIONS

 Are you ready to meet the new FDA requirements?

       The first step:

	Starting in June 2009– Only electronic submissions for drug establishment registration and drug product listing will be accepted by FDA
	Paper submissions will NOT be accepted
	We can prepare and submit to FDA

       The second step, now voluntary:

	We are ready also to create eCTD submissions for APIs,  Drug Products and Drug Master Files
	eCTD submissions provide easier FDA review
	Improved FDA review translates to faster approval times and market entry

Call for further information … 732-833-1666

2275 West County Line Road, Suite 6 #324, Jackson, New Jersey 08527
Phone:732-833-1666    Fax:732-833-4833   E-mail: ira.berry@irb-c.com
Copyright © 2008 International Regulatory Business Consultants, L.L.C.