IBS-Experts International ltd. (IBS) is established in 2019 as a consultancy company for pharmaceutical industry and regulatory institutions worldwide covering active pharmaceutical ingredients, medicinal products, investigational medicinal products, medical devices and supplements for both human and veterinary use.

IBS has highly educated pharmaceutical professionals with international M.Sc. and Ph.D. degrees and experience from multinational pharmaceutical companies (EU and US FDA approved), three of them are also former EU Inspectors (GMP/GDP/GCP/GLP/GVP). All employees were also exposed to successful US FDA inspections and former inspectors were trained by US FDA as a part of US FDA and EU MRA project. Croatian Inspectorate led by our COO was among first 8 EU member states to be recognised by US FDA as equal after thoroughly evaluated by US FDA which included observation of work of our former inspectors. IBS employees are active in different scientific, regulatory, and academic working groups, also acting as trainers and speakers on conferences and webinars organised for professionals in industry, regulatory institutions and academia.

The Company was inspected by EU Regulatory Authority of Croatia (PIC/S member and US FDA approved) and received MIA license and GMP certificate in February 2022 with 4 approved EU QP’s. The GMP certificate covers importation and batch release license for finished products (sterile, non-sterile and biotechnological medicinal products). EU physical importation site, warehouse and batch testing laboratories are subcontracted with priority rights.

IBS is engaged in projects in Europe, Asia, Russia/CIS, US, LATAM, AU and Canada. Projects are very diverse and include: a market research for evaluation of project feasibility; setting up whole facilities (from design until certification including training of employees and facility equipping); technology and analytical transfers; regulatory intelligence; developing a dossier for US, EU and EAEU market; audits and MOCK audits of companies on  behalf of regulatory authorities or client companies; assisting during official regulatory inspections and supporting in post inspection activities like CAPA and communication with regulatory Agencies; training of regulatory inspectorates, EU batch release, importation and distribution, creating PQR's for clients, GxP help desk with short answer lead times.

IBS is capable to support projects with following specific language requirements: English, Swedish, German, Croatian, Russian, Ukranian, Serbian, North Macedonian, Slovenian. Employees have lived, studied and worked abroad and are finding it easy to adjust in different social and climate environments.