"We are happy to hear that Belupo was the first to submit a real eCTD to HALMED," said Martin Zlatar, regulatory specialist who prepared the eCTD submissions. "We needed to consider the differences in e‑submission interpretations between EU region and Croatia – there are additional different requirements due to the varying approaches regulatory authorities take to review dossiers. However we were able to meet specific national requirements thanks to Infotehna’s SubmissionExpert^TM, a unique all-in-one submission management and publishing solution that has been used in Belupo since 2005".

"It was really a pleasure to work with highly motivated colleagues from Belupo," said Dragica Matejaš, senior project manager at Infotehna Group. "In just a few days we achieved that Belupo’s regulatory professionals can build and submit Croatian eCTD submissions independently."