Marketing authorization of drugs, food supplement, cosmetics and medical devices.
Clinical and pre-clinical study.
Certification according to GMP in Russian Federation and EEU
Rely on genuine professionals of Medical Certificate LLC to register your product:
- Deep understanding of pharmaceutical market and qualified analysts (applying IMS Health)
- Up-to-date information about trends of pharmaceutical market
- High quality service and professional etiquette
Starting from preparation of project documents up entering market strategy.
We guaranty compliance with deadlines and fixed project price.
Marketing authorization, regulatory support:
- Developing of marketing authorization plan and defining of budget;
- Registration of drugs;
- Registration of API;
- Registration of food supplements;
- Registration of medical accessories;
- Developing of dossier;
- Сonsulting service and implementation of complicated registration projects;
- Post-registration project management;
- Procurement of permits to conduct clinical study in the Ministry of Health
- Council of Ethics report
- Import/export license for biological and medical samples
- Regular report to regulatory authorities
- Conducting of preliminary expertise
- Pre-clinical study management.
- Developing of pre-clinical study plan: generic drugs and original drugs;
- Developing of study design;
- Web site selection according to the study design;
- Pre-clinical report validation.
Management and conducting of clinical study:
- Bioequivalence study (full cycle);
- Early clinical trials (I-II phase);
- Clinical trials (III phase);
- Studies on specific populations;
- Post-registration study (IV phase);
- Non-interventional study;
- Clinical study for medical devices.
Data management and E-services:
- Electronic case report form;
- Development and management of data base;
- Statistical data analysis;
- Validation of e-systems and data base.
Scientific support and consulting:
- Analysis and preparation of clinical study documents;
- Scientific consulting for study design;
- Reports according to obtained data;
- Pharmacoeconomic study.
- Developing and implementation of safety measures;
- Preparation of documents for Pharmacovigilance;
- Continuous monitoring of product safety on the market;
- Communication with regulatory authority;
- Communication with patients and other information sources regarding adverse event;
- Control and analysis of adverse events during clinical studies;
- Conducting of trainings and seminars regarding Pharmacovigilance;
- Preparation of regular reports on cases of adverse events;
- Preparation of regular reports on product safety;
- Licensing of foreign pharmaceutical manufactures (according to GMP)
- Issuing of GMP certificate
- Preparation of documents for Ministry of Industry and Trade of the Russian Federation
Quality management system:
All operations are conducted according to the standard operation procedure (prepared according to the GMP).
Medical Certificate LLC consults clinical facilities of early clinical trials on the developing of the standard operation procedure.
- Thanks to IMS Health software our company is able to analyze the market and prepare a product portfolio to successfully enter the Russian pharmaceutical market.
- We have our own pharmaceutical warehouse, which meet the requirements: GMP, GDP, GSP
- Full range of «turn-key» services. We support your product starting from strategy development up to introduction of products to the market.