Legal support of clinical and preclinical studies
Legal services (legal assistance) in the legal support of clinical and preclinical studies
Legal support of clinical and preclinical studies is an important area of practice at BRACE Law Firm.
Healthcare and pharmaceuticals are key areas of industry specialization for lawyers at BRACE Law Firm, in which we provide legal services to manufacturers and distributors of medicines, medical devices, dietary supplements, and other healthcare organizations on issues of Russian and international law.
Conducting preclinical studies of medicines
Preclinical (non-clinical) studies are studies are the initial stage of medicines development and do not involve the participation of people.
A preclinical study of a medicinal product for medical use is carried out in Russia in accordance with the Rules of Good Laboratory Practice, containing requirements for testing laboratories, research protocols, as well as the direct procedure for conducting preclinical studies.
The results of preclinical studies of medicines are a necessary supplement to the dossier of medicines for registration examination and subsequent registration of medicines in Russia.
Conducting clinical trials of medicines
Clinical trials are a process of studying the efficacy and safety of a new medicine or treatment method with the participation of volunteers and are conducted to evaluate the effectiveness and safety of a treatment or diagnostic method.
To conduct a clinical study, it is necessary to obtain a permit issued by the Ministry of Health of Russia.
The procedure for conducting clinical trials should be carried out in accordance with the requirements of the rules of good clinical practice.
Clinical studies are a necessary step in the development of a drug that precedes its registration. The circulation of drugs that have not undergone clinical trials (with the exception of cases where it has been established with respect to a number of drugs that they are not possible) is prohibited.
- Legal support of clinical and preclinical studies
- Legal support in all matters related to obtaining permission to conduct clinical trials, as well as with conducting clinical and preclinical trials at all stages of their conduct
- Development and legal examination of documents required for conducting clinical and preclinical studies
- Preparation of legal opinions on all issues related to the legal regulation of clinical and preclinical studies