Good communication is essential when developing a regulatory strategy.
For new products and concepts Regulatory agencies like to engage early in the planning process in order to steer the planning product strategy (for Pharmaceutical, Clinical and Non clinical aspects) in the right direction.
consult2deliver can help you prepare for a scientific advice meeting. We have experience of leading and initiating meetings and co-ordinating a ‘response to question’ meetings (rejection of dossier or misinterpretation of clinical data by assessment staff).
We can set up pre meetings, lead or attend face to face meetings, obtain written advice, manage correspondence and write up the scientific advice meeting output as notes for the regulatory agency in
- UK (MHRA) Get scientific advice from MHRA
- Europe (National agencies or EMA) How to submit a scientific advice or protocol assistance request
- USA (FDA – Pre IND meetings)
Pre-IND interactions should be considered as preliminary communications based on early development information, and will generally take the form of written comments that may be supplemented by teleconferences or meetings as needed and appropriate. Additions or modifications to these communications may arise as additional information becomes available, during follow-up pre-IND interactions or when an IND is established.
We start with the end in mind to ensure consistent delivery throughout development. We want to see your concept become a success.
As an SME, consult2deliver limited, understand the opportunity of external advice and validation. consult2deliver have initiated and lead scientific advice meetings at MHRA, EU National agencies, EMA and FDA.