• Advising clients on regulatory strategies in compliance with regulatory requirements
• Services of the local responsible person for communication with regulatory authorities
• Preparation and management of documentation for national marketing authorization application
• Preparation and management of national documentation for DCP and MRP procedures
• Preparation of documentation for transfer, update, renewal of marketing authorization and variation of the dossier
• Translation and preparation of drug information (SPC, PIL and labeling) in accordance with the Croatian medicinal product legislation
• Communication with regulatory authorities regarding new requirements/answers to deficiency/clarifying the shortcomings in the submitted documentation
• Preparation, proofreading and approval of packaging materials (mock-up/artwork)
• Marketing materials review, harmonization with approved medicinal products documents