Tools for e-submission
Since 1st of January 2017, an e-CTD became an obligatory format and method of submission and e-CTD software became indispensable tool for each MAH in the EU. Also, many non-EU health and regulatory authorities follow this path closely [e.g. Health Canada]. Therefore we have decided to expand our range of services. (more…)
Mobile application for reporting adverse drug reactions for medicinal products
Suspected ADR can be, as of now, reported via mobile application of Croatian Medicinal Products and Medical Devices Agency (HALMED), intended to the patients, health care professionals, caregivers and other citizens. (more…)
Serialization knocking at the door – what to expect?
Serialization process is not a new one in other industries on global level. Automotive and banking industry have already implemented it. No, pharmaceutical industry must do the same. (more…)
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