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)
- Europe (National agencies or EMA)
- USA (FDA)
We start with the end in mind to ensure consistent delivery throughout development. We want to see your concept become a success.
consult2deliver have initiated and lead scientific advice meetings at MHRA, EU National agencies, EMA and FDA, covering
- Inhaled therapies (single and combined)
- OTC medicines
- Paediatrics medicines
- Orphan drugs
- Conventional ethical therapeutic medicines