CONSULTING SERVICES

ProventPharma offers extensive consulting services on registration of medicinal products, medical devices, food supplements and cosmetics:

• Review and evaluation of your dossier for the medicinal product, medical device and food supplement to assess conformity with current legislation and regulation and eliminate deficiencies at an early stage.
• Assistance in selection of regulatory strategy (regulatory intelligence);
• Trainings and education in regulatory work;
• Assistance or full preparation of SOPs

REGULATORY SERVICE & FULL SUBMISSION MANAGEMENT

ProventPharma provides services in:

• Medical writing (non-clinical and clinical overviews and summaries)
• Preparation of QOS
• Compilation and preparation (translation, adjustment) of SmPC, PIL and labelling according to current EU requirements and guidelines.
• Readability User Testing
• Preparation of Marketing Authorisation Application (National procedures MRP/DCP)

ProventPharma provides assistance in lifecycle management of your product.

REPRESENTATION & DISTRIBUTION

ProventPharma represents Your company in Croatia providing support and services related to pharmacoeconomic analyses, market access, inclusion of Your medicinal product in the Reimbursement list of the Croatian Health Insurance Fund, marketing and sales.

PHARMACOVIGILANCE SERVICES

ProventPharma provides services of local QPPV as defined by the regulations in Croatia.