In the commercialization phase, time to market is of key importance, but there are many hurdles on the way. In the pharmaceutical market landscape, the outcome of the regulatory procedure is critical. However, gaining reimbursement and market access can determine the degree of success. Irrespective of where you are in the process, we can help you navigate by setting your market roadmap and assist you in reaching your desired destination.
Assistance to a start-up specialty pharma company all the way from product acquisition, obtaining all necessary permits and set up of third-party production, to continuous operational support.
Establishment through acquisitions is a common way of building a pharma portfolio from scratch. Often, this includes various business development challenges such as changing contract manufacturer, but it also includes opportunities to increase the profitability of the products through focused lifecycle management.
Based on the client’s requirements, we conduct a product acquisition candidate search and evaluation. We evaluate and make contact with potential sellers and can also negotiate the subsequent acquisition.
Additionally, we can assist in identification, negotiations and implementation of third-party production, manage the tech transfers and regulatory submissions including Chemistry, Manufacturing and Controls (CMC).
If necessary, our team can apply and manage the wholesale dealer license for the client and establish the distribution chain in the desired markets.
As part of the engagement we can also manage forecasting, supply and transportation, including contacts with distributors and clients.
During the life cycle of the acquired products, our support include interactions with health technology assessment (HTA) authorities regarding pricing and reimbursement.