About us
IBS-EXPERTS INTERNATIONAL d.o.o. is a company that operates worldwide and provides following services to the pharmaceutical industry with the aim of supplying/importing/releasing pharmaceutical products (medicinal products, medical devices, APIs, food supplements) and consulting for achieving quality and regulatory compliance in the areas of:
- Production and production processes
- Conducting clinical studies
- Preparation of Dossiers
- Quality assurance and Quality control
- Technology transfers
- Site surveillance on behalf of regulatory authorities (EU, US FDA, ROW)
- Audits on behalf of clients (virtual and on-site), Mock Audits
- Due Diligence Audits
- Setting up production /QC facilities from Start-ups, change in current infrastructure during all phases (from planning till final build)
- EU-GMP related services (Compliance problems resolution, document preparation/reviews, specific training, and other services)
- Manufacturing and QC systems evaluation, providing help in URS creation and providing professional help during FAT/SAT Audits
- Data Integrity consulting, support, and services
- GMP training
- CSV
- PQRs
- Cleaning validation (toxicology reports, calculations, CV matrixing)
- Process validation
- Handling mergers and acquisitions on behalf of pharmaceutical, biotechnology, medical device and/or dietary supplement companies
IBS serves all areas of GMP-related activities for the Pharmaceutical, Biotechnology, Biologics, Diagnostic, Device and Allied Health Industries. IBS-EXPERTS INTERNATIONAL d.o.o. Consultants are proficient in the development, implementation and management of diversified projects involving scientific principles, technical aspects, and regulatory requirements.
Currently IBS has 10 employees with 20+ years average of experience in the pharma industry and with 3 former EU-GMP/GDP/PhV/GCP/GLP inspectors, one of which is former head of EU GMP inspectorate (PIC/S and US FDA approved).
IBS has been recently successfully inspected for manufacturing activity of EU batch importation and batch release with secured contracting batch testing labs and warehouses assuring client prioritisation. IBS has 4 EU QPs eligible to release sterile, non-sterile and biotechnological products. IBS will provide support for any product dossier variation and analytical method transfer.
