Life Sciences Companies looking to enter the European Market have to deal with regulatory and reimbursement issues.
While the EU has a single regulatory regime, reimbursement issues are specifically country bound. The use of a particular product, for a particular purpose may be reimbursable in one country and not in another.
It bears to develop a strategic plan that addresses regulatory and reimbursement issues before commercializing the product, so the team understands (a) that there exists a pathway to success (b) what the risks are and (c) what is required to stay on that path.
Companies wanting the enter the US Market need to address regulatory, reimbursement and liability issues.
Companies have to obtain FDA approval before they can commercialize their products. They also have reimbursement issues to address. Even though they are less complex than in the EU, reimbursement is still needs to be addressed.
Most foreign companies wanting to expand in the US have concerns about entering a litigious US environment they have never been exposed to. Understanding the risks involved with entering the market, and how these risks can be mitigated becomes very important. Lack of understanding may cause them to pass on a profitable opportunity.
Entering the fast growing Asian Markets requires making choices.
The Asia Market is splintered and very fast growing. There exist very little harmonization. Some countries are further along with the development of their regulations than others. Japan, South Korea and Taiwan have stable well established regulations. In China and India the regulatory environments have recently undergone significant changes. The Asean countries are trying to harmonize their regulations and on a course of convergence.
Companies interested in entering these Asian markets will benefit from local support to navigate the myriad of obstacles. Not only regulatory obstacles but also issues of distribution, navigating foreign cultures and business practices.
Life Sciences Companies wanting the enter the US Market need to address regulatory, reimbursement and liability issues.
Companies have to obtain FDA approval before they can commercialize their products. They also have reimbursement issues to address. Even though they are less complex than in the EU, reimbursement still needs to be addressed.
Most foreign companies wanting to expand in the US enter a litigious US environment they have never been exposed to. Understanding the risks involved with entering the market, and how these risks can be mitigated becomes very important. Lack of understanding may cause them to pass on a profitable opportunity.
Companies looking to enter the European Market have to deal with regulatory and reimbursement issues.
While the EU has a single regulatory regime, reimbursement issues are specifically country bound. The use of a particular product, for a particular purpose may be reimbursable in one country and not in another.
It bears to develop a strategic plan that addresses regulatory and reimbursement issues before commercializing the product, so the team understands (a) that there exists a pathway to success (b) what the risks are and (c) what is required to stay on that path.
Entering the fast growing Asian Markets requires making choices.
The Asia Market is splintered and very fast growing. There exist very little harmonization. Some countries are further along with the development of their regulations than others. Japan, South Korea and Taiwan have stable well established regulations. In China and India the regulatory environments have recently undergone significant changes. The Asean countries are trying to harmonize their regulations and on a course of convergence.
Companies interested in entering these Asian markets will benefit from local support to navigate the myriad of obstacles. Not only regulatory obstacles but also issues of distribution, navigating foreign cultures and business practices.