Dossiers preparations

• Developing regulatory submission strategies
• Preparation of the new applications or upgrading of existing documentations according CTD format requirements
• Assessment of actual state and quality of available documentation
• Preparation of renewals and documentation for variations and follow-up on their evolution.
• Preparation of Quality Overall Summary; Nonclinical overview; Clinical overview as required by EU CTD guidelines.
• Preparation of Summaries of Product Characteristics and Patient Information Leaflets (SPCs and PILs)
• Preparation all labeling texts for the products in accordance with local requirements and clients SOPs.
• Preparation of Periodic Safety Update Reports (PSURs)
• Organization and implementation of pharmacovigilance. Identification, monitoring and response to new findings in respect of drug administration risks or drug interaction with other products or substances
• Registration of medical devices
• Continual monitoring of the registration process up to the point of obtaining the marketing licence for releasing medicines and medical devices