At BlueReg we share the passion for the development process and are motivated by the prospect of helping others with new products (pharmaceuticals, advanced therapies or medical devices) or therapeutic indications. Our consultants have come from similar environments as our clients and have ‘walked in their shoes’. As a result, the working relationship during such projects is special and the real collaboration between consultants and client stakeholders blurs the lines of client / service provider.
Product development to BlueReg means setting out a regulatory roadmap, a pathway towards approval in the target market and target therapeutic indication. It means helping clients navigate through the process of discussing their projects and challenges with regulators through Health Authority meetings, and lastly in this section, preparing a regulatory application dossier (New Drug Application or Marketing Authorisation Application) that showcases the intention of the applicant. All of which is not just about strategy but hands on support to write and prepare the regulatory submissions.
It is important to be able to makes decisions based on all the available input and data. Therefore, the sooner a project can be shared to obtain our input the better. Our experience with other client activities can provide valuable insight to the challenges ahead. Regulatory roadmaps are developed in a similar manner to Target Product Profiles with the end in mind and regularly scrutinised and developed as more data become available.
Regulatory submission planning is a team effort with multiple inputs and stakeholders. It is preferable to develop the regulatory submission strategy early and implement a tactical action plan to ensure that deliverables are met according to expectations. Early investment in time pays dividends in the overall project timelines as it ensures all stakeholders are driving towards the same goals with the same set of assumptions.