Request for service

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Application for medical device development service

Application for Medical Device QMS Service

Application for medical device registration service

Application for registration of medicines

Request for service of amendments to RC/RD

Request for marketing research service for MD and Pharmaceuticals

Application for technical and medical translation

Pre-registration research

Drug development, pre-clinical and clinical studies. Preparation of reports confirming the safety, quality and efficacy of the drug.

Preparation of a complete set of documents in the Common Technical Document (CTD) format and submission of the application to the regulatory authority.

Submission of the registration dossier

State registration of medicinal products manufactured in Russia or imported from other countries and intended for circulation within the Russian Federation is a mandatory procedure.

Analysis of the submitted documents by the regulatory authority. Conducting an expert evaluation by an authorized organization of the proposed methods for quality control of the medicinal product and the benefit-risk ratio of the drug's use.

Expert evaluation

Registration is carried out by the Ministry of Health of Russia based on the results of examinations conducted by a subordinate institution and confirms that the drug has undergone preclinical and clinical trials, its use is not associated with an unacceptable risk to health, the drug has the claimed therapeutic effect, and complies with all legal requirements in the field of medicinal product circulation.

The process of drug registration is quite lengthy and includes several stages

Making a decision on the registration or refusal to register the drug.

Registration decision

Before starting the registration process, the specialists at RZN.Expert will provide consultations on registration issues and the composition of the registration dossier.

Consultations on registration issues

01

Determine the registration strategy based on the requirements of the state and competitive environment.

Development of a registration strategy

02

At this stage, our experts will help with the selection and processing of documents. Formation of a registration dossier.

Preparation of registration dossier

03

Sending the registration file to the authorized authority.

Application for registration

04

During the registration process we represent our clients' interests and conduct negotiations with the relevant authorities. In case of a positive decision of the expert examination, the registration certificate is issued.

Interaction with state bodies and obtaining registration certificate

05

One important aspect of drug registration is the control and assurance of quality and safety. Experts of PZN.Expert will help to develop and implement a control system that meets the requirements of state authorities.

Post-marketing monitoring

06

Our specialists have a deep knowledge in the field of pharmacy and legislation. We guarantee the high quality of services provided and compliance with all regulatory requirements.

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Highly qualified personnel with specialized education

Only specialists with a specialized education in the fields of chemistry, biology, chemical technology, biotechnology, microbiology, biochemistry work at the company.

Collaboration with specialized organizations

We cooperate with leading specialized universities, medical organizations and manufacturing enterprises.

Unique automated techniques using artificial intelligence

The company uses unique, automated methods of developing documentation using artificial intelligence technologies. This improves the efficiency and quality of work, as well as allows to optimize costs.

Entrust this process to the professionals