Regulatory activities

Long Sheng Pharma is a true expert in registering:

• Active Pharmaceutical Ingredients (API);
• Medical devices;
• Finished Dosage Forms (FDF).

We are ready to assist you with dossier compilation, clinical trials, and registration regulations in the Russian Federation.

1. Registration and dossier compilation for FDF, medical devices

• Preparation, assessment, regulatory documents revisal, translations, submitting the dossier to the Ministry of Healthcare of the Russian Federation, obtaining import authorization for unregistered FDF.

2. Regulatory submissions assistance of API

• Dossier audit and compilation, document translation, normative document preparation, submitting the dossier to the Ministry of Healthcare of the Russian Federation, pharmaceutical examination assistance and tracking, issuing the authorization to include pharmaceutical substance in the State register of medicines.

3. Registration of medical devices

• Technical file audit, dossier audit and compilation, obtaining an import permit of medical devices for the registration, translations, technical and toxic test management, submitting the dossier to The Federal Service for Surveillance in Healthcare (subsidiary control body of the Ministry of Health of the Russian Federation), clinical trials management, registration tracking, obtaining the registration certificate.