Regulatory Representation

Do you need a representative for your product in the market?
You are in the right place!

We are with you throughout the life cycle of your product...

…from an idea…

You have recognized the potential of the market and want to launch your product.

…through the analysis of the needs of your company…

You need the advice of an expert who has excellent knowledge of local regulations.

...and choosing the right solution...

Together we create a plan of further activities tailored to the needs of your company.

…to realization!

With a good plan, further steps are taken, from approving your product to monitoring the life cycle in the market.

In the Republic of Serbia and in Montenegro,product registration is a long-lasting regulatory process, which leads to high costs for companies interested in operating in these markets.

KK Pharma Leader provides reliable and efficient regulatory assistance as a MAH in the Republic of Serbia and Montenegro for medicines, or as an authorized representative for medical devices, and represents your company before National Regulatory Authorities.

If you are planning to place your products on the Serbian or Montenegrin market, or you want to expand your current business portfolio, our team can help you with that. KK Pharma Leader provides regulatory representation services to trusted manufacturers throughout the product life cycle. We can act as an independent regulatory link from your chosen distributor or actively cooperate with them, in accordance with your company's policy.

Republic of Serbia:

Tiršova 5a, Savski Venac,
11 000 Belgrade, Serbia

Montenegro:
Dositejeva 75
85310 Budva, Crna Gora

Office Hours:

Monday - Friday
08:30 - 16:30
Office Hours:
Monday - Friday
08:30 - 16:30

Business Data:

Name: KK PHARMA LEADER D.O.O.
ID Number: 21417823
Tax ID Number: 111043766
Business Data:
Name: KK PHARMA LEADER D.O.O.
ID Number: 51243100
Tax ID Number: 03675785