Agency responses (RSIs)
A successful marketing authorisation requires efficient and appropriate responses to agency questions and objections. BioVentures Consulting Limited can advise at this crucial stage of the assessment process, providing input on the interpretation of questions and major objections, understanding requests for supplementary information (RSI) and additional documentation that may be required; and the presentation format for a response package.
BioVentures Consulting Limited applies strong science to enhance the robustness of responses
BioVentures Consulting Limited has a core competence in understanding the scientific issues behind drug development programmes, and those scientific issues which so often underpin major objections following the regulatory review procedure. BioVentures Consulting Limited applies strong science to enhance the robustness of responses and rebuttals. Many examples occur with biopharmaceutical products, where the regulatory procedures of responding to questions and major objections also differ between the US and Europe. In Europe submissions for biotech products must go through the Centralised Procedure, in which an Applicant has one main opportunity to satisfactorily address questions from the CHMP assessors. Hence, in order to secure a positive Opinion upon review of the responses, it is essential that the Applicant understands the questions (and to be able to pinpoint the exact nature of the objection) and any additional data requested, the level of detail required in the response and the format and timing of the response. This review process contrasts with the US, where review starts at the IND stage and continues in a more repetitive manner through to the filing of a Biologics License Application (BLA).
Our expertise in compiling succinct, well-argued rebuttals as part of the response package can be invaluable
BioVentures Consulting Limited has experience and expertise in interpreting consolidated lists of questions and objections, which need to take into account the preliminary and final assessment reports provided by the Rapporteur and Co-rapporteur. Regulatory assessors appreciate well-organised responses, and a clear presentation of the data, which directly address the issues raised. This allows them to conduct an efficient review, when their time to review the response package in a time tabled process, is limited. Our expertise in compiling succinct, well-argued rebuttals as part of the response package can be invaluable.
Having clearly stated the importance of understanding the science behind the product, BioVentures Consulting Limited prefers to get ‘right to the detail’ of the product and its development history. Our preferred policy is to work with our client company to understand the product and its development issues ‘inside out’ – from the assay development, product specifications (and how these may vary in different regions), validation methodologies, production ingredients, clinical end-point selection, dose level rationale, patient inclusion criteria, and so on. It is only through a detailed understanding of the science and of the technologies applied that robust responses can be make to regulatory agencies following product assessment review and opinion.