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
Pharmalex provided the resources we needed to compile Investigational Medicinal Product Dossiers for our biological products. The dossiers were delivered on time with the trusted quality we expected
Sr Director Regulatory Affairs CMC
During the bid defense we felt that you worked well as team and are very dynamic. Preparation of such a complex dossier really needs to be done in such a way.
VP Regulatory Affairs