One of our core service offerings is
Pharma Market Access Services
Kepler is one of the top pharmaceuticals market access and registration company in the Gulf region.
Each country in the Middle East, and more specifically, the GCC/ Gulf countries – Saudi Arabia, United Arab Emirates, Kuwait, Qatar, Bahrain, and Oman, have different pharmaceutical product classifications and product registration documents requirements. For example, products which are registered as Food Supplements in Europe or USA may be classified as food supplements in Kuwait, health products in Bahrain, herbal medicines in Qatar, and dietary supplements in the UAE. So each country will have different requirements to register. Further, the time taken to register the product also varies depending on the classification.
Many manufacturers make their own assumptions about their target market, and unfortunately, they either underestimate or overestimate the market, depending only on market share and automated analysis.
What Kepler offers
We at Kepler believe that market share and general data about population and purchasing power are not the only determining factors for pharma, supplements, medical devices products registration. There are many other not-so-obvious factors such as market dynamics, customer behaviour, customer requirements, etc. Since our team have feet on the ground and are already working directly with customers, our market feedback is far more reliable and accurate.
Get the easiest registration classification with least requirements
Guarantees quick market access in the GCC countries
Our regulatory team has tremendous experience in registration
Using the best resources & relations that fits the product category
With Kepler, you can be assured that we will help you to get the easiest registration classification with least requirements, which guarantees quick market access for your products in the target GCC countries. Our regulatory team has tremendous experience in registration of all types of pharma products, medicines, devices, and food supplements. For market access for complicated pharmaceutical products, we can guide you and prepare the requirements with you. We use the best resources and relations to ensure the best type of registration that fits the product category.
We provide three service models for pharma market access in Gulf countries. These are designed to serve you better by offering you the flexibility in choosing the relationship you want with us. Our service fees also depend on the product file and category. Please bear in mind that we provide market access services free of charge if Kepler is given the distribution rights for the product for the target country.
Here’s a brief outline of our pharma market access and registration services categories:
We assist you with all that you need for your product registration, we will advise you with what are the possible categories your products will fall under, explain to you the requirements for each product category, and provide to you the official registration documents needed either from ministry of health or municipality of the targeted country.
Many manufacturers come to us when their submitted registration files are stuck for market access approval, or their products fall under a tough classification wherein the documentation requirements are extremely stringent. In such cases, where you have already submitted your market access documents to the concerned authorities, we can check if your available documents are sufficient for registration, provide you with a list of missing documents, advise you if you can get an alternate, easier classification, and guide you on how you can prepare all the documents needed to register your product quickly and easily.
We help you to register the product in the selected country along with a comprehensive strategic plan to penetrate the market in the way you desire. We will advise you about competition, explain the market dynamics, what tools you need to penetrate, how to win against competetion, and answer all questions you may have regarding market access.