Medicinal products

NOVE OBAVIJESTI

Poštovani klijenti, obavještavamo Vas da od 19.10.2020., radi primjene mjera za sprječavanje širenja zaraze SARS-CoV-2 virusom, umjesto kontaktnih seminara svi seminari će se održavati kao online seminari. Molimo Vas da pogledate novi, izmijenjeni raspored svih seminara, a za dodatne informacije slobodno nas kontaktirajte. 

Usluge poslovnog savjetovanja: uvođenje sustava kvalitete i drugih sustava upravljanja (ISO standarda); usklađivanje sa zahtjevima dobre proizvođačke, distribucijske, laboratorijske ili kliničke prakse (GMP, GDP, GLP, GCP); izrada dokumentacije o proizvodu - PIF („Product Information File“) za kozmetičke proizvode; dopuna tehničke dokumentacije za medicinske proizvode u skladu s novom uredbom; izrada kliničkih evaluacija za medicinske proizvode; podrška kod validacije računalnih sustava; validacija excel predložaka; statistička obrada podataka; stručni prijevodi (iz područja GMP, GDP, GLP, GCP, ISO); te provedba audita i dalje su dostupne - na daljinu (on-desk).

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SUPERA KVALITETA provides business consulting services in the field of medicinal products for the implementation, maintenance and improvement of:

  • Good Manufacturing Practice - GMP
  • Good Distribution Practice - GDP
  • Good Laboratory Practice - GLP
  • Good Clinical Practice -GCP
  • Good Pharmacovigilance Practice - GVP
  • Good Automated Manufacturing Practice - GAMP
  • Quality Management System - QMS

Our activities also include project planning and their regular review, support during product development and portfolio management, design for renovated or new facilities (laboratories or pharmaceutical manufacturing facilities), as well as support during the development and validation of computer systems (SDLC), data integrity, and compliance with GAMP. We are able to train staff at all levels of the organization and interact with them, establish and motivate teams to process improvements and lead company-wide programs that result in significant cost reductions.

With our help, our clients have successfully implemented and improved their quality system, aligned it with Good Practice Requirements (GxP) and received approvals or certifications from regulatory bodies such as the Ministry of Health of Republic of Croata, US FDA, EU, PIC / s and WHO.

We also perform internal audits and third-party audits in compliance with applicable regulatory requirements and standards. 

We organize and perform in-house trainings in English language for GxP, risk management, internal audit performing and other topics in the field of medicinal products.

For non-EU companies we offer representation service in the process of submitting the application for GMP certificate to the Agency for Medicinal Products and Medical Devices of Croatia (HALMED) in Zagreb, Croatia as well as its services in communication with the HALMED in the process of obtaining the GMP Certificate.