Regulatory support
Smooth Drug Development provides regulatory support services in clinical trials.
Regulatory support is a complex process which ensures that parameters of clinical development process meet its main goal – obtaining of a marketing authorization.
Main steps of the regulatory support:
- Preparation of the registration strategy
- Obtaining of a clinical trial regulatory approval
- Acceptance of the study results to go to the next phase of development
- Acceptance of the clinical program results for marketing authorization
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 different therapeutic areas
- Preparation of the pre-clinical and clinical research program
- Preparation of the draft patient leaflet
- Requests to regulatory authorities regarding sufficiency 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
There are two major regulatory risks:
- Refusal to grant permission to conduct a clinical trial (wrong choice of study design, patient population, endpoints, a reference drug, statistical methods of sample size calculation and evaluation of results, a risk-benefit ratio, a lack of data collected in preclinical or in previous clinical studies)
- Refusal to grant marketing authorization based on results of successfully conducted registration study (wrong phases of clinical development, wrong choice of study type for the purposes of registration, lack of reported data, incorrect methodology of the study)
To avoid the above risks it is necessary to evaluate the entire clinical development program. We collaborate with professionals from various scientific fields to comprehensively predict possible outcomes of clinical research and achieve expected results. If necessary we make requests to the regulatory authorities to obtain scientific advice.
We provide the following regulatory support services:
- Design of clinical development program and registration strategy
- Development of clinical research documents
- Amendment of documents before a clinical trial application to the Regulatory authorities
- Consulting with Regulatory experts
- Clinical trial application to the Regulatory authorities
- Ongoing submission to the Regulatory authorities
- Final report submission to the Regulatory authorities