Confidence Beyond Compliance
Understanding the differences in legislation, national guidelines and medical practice across different regions and/or countries is essential when planning your regulatory strategy. The way a particular medical condition is managed and the standard therapy used can differ and in turn affect the approach you take. A key challenge is successfully navigating the regulatory landscape. This information can sometimes be difficult to obtain without access to specialists based within the appropriate area. Sometimes a significant amount of research is needed to determine which comparator or endpoints in a clinical trial will satisfy the requirements of the local regulatory authority. This is particularly true for innovative therapies or for orphan indications.
Having a thorough development plan, therefore, will help market activities post-launch. We will support designing a strategy that will clearly define the end goal, aligned with product attributes and agency requirements. This will determine where to best market and implement a new product. The process commences with a detailed gap analysis and will include periodic regulatory intelligence and competitor monitoring to make sure that the development strategy meets all regulatory requirements. We will document where a deficiency may need to be addressed to ensure the product is meeting all regulatory guidelines throughout the product’s current development process.
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Drug Safety Director
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