Regulatory support

iPharma offers regulatory support services for the clinical trial process.

Regulatory support is a complex process which ensures that clinical development parameters are in compliance with the main goal – to obtain a registration certificate.

Key stages of regulatory support include:

registration strategy development;
obtaining the clinical trial permit;
obtaining study results in order to advance to the next stage of development;
obtaining study results for state registration of the drug.

Registration strategy development involves the assessment of available information about the drug and preparing a program of pre-clinical and clinical research of the product, which is necessary in order to register it for one or more indications.

Registration strategy includes:

analysis of data, obtained during pre-clinical and clinical trials

study of information about similar registered products

assessment of the possibility of registration of the product for specific indications

development of the pre-clinical and clinical study plan;

drafting the instruction for medical use

contacting regulatory authorities on the matter whether the planned trials are sufficient

calculating the timeframes and costs of the study program and the product registration process

There are two main risks associated with the regulatory authorities:

Denied request for clinical trial conduct

This can happen due to the incorrect choice of study design, patient population, final points, comparison drug, sample calculation and result assessment methods, the risk-benefit ratio or insufficient data obtained during pre-clinical trials or previous studies.

Denied registration permit after a successfully completed study

The reasons may include incompliance with the clinical development process, the wrong choice of study type for registration purposes, insufficient data obtained or the wrong study conduct methodology.

To avoid these risks, it’s necessary to view the study program as one whole. Our company attracts professionals from various fields so that all possible study results are accounted for in a multi-disciplinary fashion and our goals are achieved. If necessary, we form official requests for regulatory authorities to obtain recommendations for certain questions.