Our services in this area are as follows:
- Collection and writing of Registrational Dossier documents in accordance with the requirements of the legislation of the respective country;
- Preparation of documents for the Registrational Dossier: administrative documents, description of pharmaceutical properties, technological data, and information on the results of pre-clinical and clinical studies of the drug;
- Submission of the Registration Dossier to the Regulatory Authorities;
- Qualified support and interaction with the Regulatory Authority at all stages, processing of official requests and letters;
- Obtaining and providing the client with the Registrational Certificate for the drug.
