For biopharmaceutical products, successful applications for marketing authorisation require a strong scientific approach, positioning the product appropriately. A regulatory strategy needs to take this into account. ERA offers constructive input in the development of a regulatory strategy and can organise and mediate meetings with regulators to evaluate and obtain agreement on strategies for product development.
Without a secure regulatory strategy, development of a product is, at best, inefficient and, at worst, liable to failure at the regulatory assessment stage. Devising a coherent regulatory strategy is not just a matter of knowing guidelines; it requires profound experience as well as an understanding of the science behind the product. With our proven track record of success with applications for marketing authorisation, even of very complex biopharmaceutical products, the ERA team is confident in proposing strategies that will be effective and successful. Our policy is to work with our client company, gaining an understanding of the technology and adapting a strategy accordingly. Above all else, however, such strategies should be explained and discussed with regulators at milestone stages of product development.
Our services can be summarised as follows:
- Drafting of an overall regulatory strategy for the development of a biopharmaceutical product
- Compiling of a skeletal dossier (annotated table of contents) showing the required documentation and level of detail for a submission
- Organisation of interested party meetings with regulators; preparation of briefing documents
- Preparation for meetings with regulatory assessors; definition of goals; support at meetings; follow-up with amendment of strategies