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.
What our clients say
Our project team were very impressed with the quality of the research and the reports that you sent through. We didn’t need any convincing that your recommendations should be followed. It showed PharmaLex in a very positive light, and the Project Team are keen to work with you again.
Head of Medical Writing and Publications
PharmaLex is dedicated to delivering a comprehensive portfolio while their modular approach allows tailor-made solutions. They acknowledge our feedback, modify their approach and adapt accordingly.