Service Areas
Long Sheng Pharma sets high standards to the range of services we provide our clients and customers with. Our offer goes beyond after sales service to the professional expertise, regulatory submissions assistance, effective managerial counseling for those aspiring to enter Russian pharmaceutical market.
OUR INTERNATIONAL PROFESSIONAL TEAM
- At hand counseling of our experts and analytics,
- Updating on the latest changes in the Russian regulatory system;
- Strategic management for potential and existing pharmaceutical players.
Regulatory submissions assistance
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.
- 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.
After sale service
Long Sheng Pharma puts clients and customers at high priority for further excellence in business performance.
We offer you a unique package solution that comprises shipping, assembling, adjustment, specialist training, and as a bonus – prompt expert advice in working hours.
Engineering services
Long Sheng Pharma is engaged in building and construction, as well as optimization of pharmaceutical projects. We deliver the following business solutions:
- Expert counseling in pharmaceutical equipment, packaging materials;
- Development and construction of turn key projects in pharmaceutical industry;
- Customized equipment matching on demand.