SERVICES
1. Registration of original medicinal product Read more:
Drafting registration dossier on the basis of the Customer’s materials;
Making arrangements for translation and notarial certification of the materials for the registration dossier;
Developing draft Regulatory Documentation/Manufacturer’s Monograph;
Developing package design;
Drafting the Basic Prescription Information
Organization and follow up of preclinical trials of medicinal product;
Organization and follow up of clinical trials of medicinal product;
2. Registration of generic medicinal product Read more:
Drafting registration dossier on the basis of the Customer’s materials;
Making arrangements for translation and notarial certification of the materials for the registration dossier;
Developing draft Regulatory Documentation/Manufacturer’s Monograph;
Developing package design;
Drafting the Basic Prescription Information
Organization and follow up of preclinical trials of medicinal product;
Organization and follow up of clinical trials of medicinal product;
3.Registration of medicinal product permitted for medical use in the Russian Federation for more than twenty years Read more:
Registration of medicinal product permitted for medical use in the Russian Federation for more than twenty years
Drafting registration dossier on the basis of the Customer’s materials;
Making arrangements for translation and notarial certification of the materials for the registration dossier;
Developing draft Regulatory Documentation/Manufacturer’s Monograph;
Developing package design;
Drafting the Basic Prescription Information
Organization and follow up of preclinical trials of medicinal product;
4. Introduction of amendments to registration dossie Read more:
1) Introduction of amendments to the documents contained in the registration dossier for any registered medicinal products for medical use that are not subject to expert examination;
• Minor changes.
Minor changes include: change of ownership of marketing authorization; substitution of provider of release quality control; changes in design and marking of the package; changes in the Basic Prescription Information in paragraphs according to Part 2 Art. 30 of the Federal Law No. 61-FZ of April 12, 2010 On the Circulation of Pharmaceuticals, which do not require any expert examination of medicinal product; changes due to correction of any technical, spelling, punctuation, grammar, speech and stylistic errors.
2) Introduction of amendments to the documents contained in the registration dossier for any registered medicinal products for medical use that are subject to expert examination.
• Change of shelf life, material of immediate package or storage conditions;
• Changes to test methods, standards or introduction of a new quality index;
• Change of manufacturer of active moiety;
• Change in composition of additive agents;
• Change in the manufacture participants (new production site, filler, packer);
• Changes in the Basic Prescription Information concerning the efficacy and safety profile;
5. Importation of samples and standards for clinical trials and medicinal product quality assessment Read more:
1) Calculation of medicinal product samples and standards for quality assessment;
2) Obtaining of Permit for importation of samples from the Ministry of Health of the Russian Federation;
3) Organization of delivery of samples and standards to the expert examination organization of the Ministry of Health of the Russian Federation for quality assessment.
