Marketing authorisation

• Management of regulatory licences
• Pre-submission evaluation of the technical data (chemistry/manufacturing, preclinical, clinical).
• Determination of the regulatory strategy.
• Compilation and filling of the dossiers for marketing authorisation applications based on the requirements specific to each country.
• Submissions of the dossiers.
• Follow-ups.
• Compilation of answers to the letter of deficiencies received from the different authorities.
• Permanent contact with the health authorities.

 Post-marketing authorisation

• Dossier maintenance services.
• Line extensions.
• Variations.
• Renewals.

Others

• Negotiations with the authorities.
• Adaptation of the available EU CTD dossier in regard to the national requirements.
• Compilation of label and package leaflet.
• Translation services.
• Preparation of expert reports.
• Dossier requirements for Rx drugs, OTC, food supplements, Generic drugs, herbals, medical devices.