Project management and planning

CIS registration requirements vary from country to country. Mutual recognition of studies in this region is a very complex issue. However, it is always true that in any selected CIS country such as Russia, Ukraine, Kazakhstan, Moldova or Belarus all required studies can be divided into 2 groups:

1) Studies, that should only be made locally (usually these are efficacy trials and residue)

2) Studies, that should be made locally or imported (or imported only).

Group 2 is the category which needs most attention and especially when it comes to Kazakhstan and Moldova. Registration holder must provide toxicological and ecotoxicological study reports that cannot be ordered locally, because there are no CROs which are able make it.

And here comes the quest what country accepts what studies and which laboratories qualify. There is no uniform principle or law applied on that. The decision is made on case-by-case basis and often based on precedent and expert’s opinion. Usually there is more than one option for having some studies, especially toxicological studies, performed. Our client would need a strategy where many issues are to be considered. How attractive is this or that option in terms of price/quality ratio? Where will this study be accepted? Where does it need to be accepted today?

Polgar ACRO helps the customer to prepare a comprehensive assessment of all the options and create a “study map” which is to provide the best strategic solution for the generation of product core dossier.

Polgar has an umbrella structure and our client only needs to deal with our Hungarian office even if registrations are run in several focus countries. Each registration is assigned to one of our managers in Budapest and thus a client always has one responsible contact-person for all cases.