Marketing Authorization
OCT is your trusted marketing authorization partner for clinical trials in Eastern Europe.
OCT is your trusted marketing authorization partner for clinical trials in Eastern Europe.
Our team offers a full range of high-quality services for marketing authorization for sponsors.
Our support includes:
• Preparation of a document dossier: administrative documents, description of pharmaceutical properties, technological data, and information about the pre-clinical and clinical studies of the drug
• Submission of the dossier to the local Ministry of Health
• Qualified support and communication with regulatory authorities, processing of official enquiries and letters
• Obtaining a marketing authorization certificate