Smooth Drug Development helps its Clients to design a registration strategy for novel and generic pharmaceutical products.
Development of registration strategy includes evaluation of the available information on the drug and preparation of the pre-clinical and clinical research program required for the purposes of marketing approval obtaining for one or more indications.
Preparation of a registration strategy involves pre-clinical specialists, medical writers, biomedical statisticians, specialists in drug registration and regulatory support, as well as project managers with relevant experience. If necessary, our specialists will make requests to regulatory authorities for detailed advice.
Registration strategy includes:
- Analysis of available pre-clinical and clinical data
- Analysis of information on similar registered products
- Analysis of registration possibilities in dufferent therapeutic areas
- Preparation of the pre-clinical and clinical research program
- Preparation of the draft patient leaflet
- Requests to regulatory authorities regarding sufficience of planned program
- Estimation on the terms and costs of the research program and marketing approval
As result of the analysis we provide a detailed report that contains:
- Draft patient leaflet
- Expert evaluation of performed studies
- Information about necessary pre-clinical studies
- Information about necessary clinical trials with:
- Recommended clinical development phases
- Recommended study design in each phase
- Approximate number of subjects in each phase
- Product registration procedures for special patient groups