Regulatory Strategy & Intelligence
An overall regulatory strategy is essential for successful drug and medical device development and has the perspective of shortening the time to market. Regulatory intelligence forms the basis for the appropriate strategic considerations and consists of essential components such as choices related to the procedure to follow, the regulatory environment, and legal requirements.
Our regulatory intelligence service can visualize the regulatory landscape associated with the drug development and approval process. We investigate historic decisions of regulatory agencies relevant to your product to anticipate on future decisions. We consider relevant regulations and guidance documents and investigate competitor products for example patents and market exclusivity.
When facing the challenge of developing a medicinal product, you have to consider the pharmaceutical, non-clinical and clinical development. In addition, regulatory requirements need to be implemented in the development process. To do so you need to design a regulatory strategy. Whether your product is an innovative small molecule, a biological or an ATMP, or whether the product is a generic or a biosimilar: Xendo can draw the regulatory landscape for your product and develop a regulatory strategy. Our strategic regulatory support is also relevant in the context of a merger, acquisition or strategic alliance and partnership. We can outline a strategic planning and execution with consequential steps to be taken, like the legal and regulatory aspects of the negotiations, submission of the request of MAH change, We can support the due diligence and formulate a regulatory benefit/risk assessment.