Medicinal Products
Pre-authorisation activities
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Support in defining the best product registration strategy, including the type of procedure to be followed;
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Preparation, Submission and Follow-up of Marketing Authorisation Applications (MAA), under National, Mutual Recognition, Decentralised or Centralised Procedures
Post-authorisation activities
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Preparation, Submission and Follow-up of Marketing Authorisation:
· Variations;
· Renewals;
· Revocations;
· Transfers.
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Management of the review and validation of promotional materials
Technical and scientific support
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MA Dossier Gap Analysis;
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Review of module 3 – Quality;
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Preparation of sub-module 2.3 – Quality Overall Summary;
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Elaboration and/or review of Summary of Product Characteristics (SmPC), Patient Information Leaflet (PIL) and Labelling texts;
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Update of QRD (Quality Review of Documents) template of SmPC, PIL and Labelling texts;
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Elaboration and/or review of SmPC, PIL and Labelling mock-ups;
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Preparation of Readability Tests and Bridging Reports;
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Others.
Medical Devices
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Market placement support;
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Elaboration and/or review of technical documents;
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Elaboration and/or review of label and instructions of use;
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Compliance with the applicable norms and guidelines;
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Registration/notification to the Competent Authorities;
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Monitoring and Market Surveillance;
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Person Responsible for Regulatory Compliance;
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Responsible Person.
Cosmetics
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Market placement support;
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Elaboration and/or review of PIF and RAS;
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Elaboration and/or review of label and instructions of use;
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Compliance with the applicable norms and guidelines;
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Notification to the Competent Authorities;
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Monitoring and Market Surveillance;
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Responsible Technician.
Food Supplements
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Market placement support;
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Elaboration and/or review of label and instructions of use;
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Compliance with the applicable norms and guidelines;
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Notification to the Competent Authorities;
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Monitoring and Market Surveillance.
Liaison with Competent Authorities