There are numerous perspectives to include when planning the geographical expansion for your pharmaceutical product. At Arex, we offer strategic advice and operational support for your successful expansion into new markets.
There are several external factors that may impact your chances of successful entry in new markets. An FDA/EMA approval open many doors, but strategic decisions should be based on the nature of your specific project. Make sure to consider the following in your strategy:
Quality requirements may vary from market to market. Does your case fulfill the local test level requirements? Does the market require final release to be performed locally?
Do the markets require local QP release, staff or offices? Do you need a local partner for submission and communication with the Health Agency?
Are your products and supply chain adapted to the climate conditions in your desired markets? Do you have the required stability data to confirm storage and distribution?
Do you need to show bioequivalence on the native population to bridge your clinical data?
Do you need translation and linguistic review of product information or other medical and technical documents that are required for expansion to EU markets?
Have you performed user readability testing of package leaflet and labelling?
What are the requirements for serialisation in the market and how will that impact the labelling of your product? Do you need a new unique code to be added on the primary and secondary part of your container closure system?
Erik Hedner
Staffan Thunell
Founding partner
BSc Economics and BA
Staffan has a long background in entrepreneurship within the life science industry. He has 20+ years experience from positions as Founder, Chairman, CEO and CFO within medical affairs consulting and small pharma. Previously Staffan worked in executive positions in big pharma and specialty pharma companies.
