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Our Services
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Regulatory activities
We advise our clients on regulatory strategies
Pharmacovigilance
Educate company personnel in pharmacovigilance
Pharmacoeconomics
We prepare applications for enlisting medicinal products
Good bussines practices
We offer consulting services in GxP-a
Translations
We offer high-quality medical translations
Constant improvement and tracking the global trends are our greatest advantages.
We are helping you to place your product/device in the shortest possible timeline with reasonable and flexible business costs.
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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…)