Regulatory Affairs

Medicinal Products

 

Pre-authorisation activities 

  • Support in defining the best product registration strategy, including the type of procedure to be followed;

  • Preparation, Submission and Follow-up of Marketing Authorisation Applications (MAA), under National, Mutual Recognition, Decentralised or Centralised Procedures

 

Post-authorisation activities  

  • Preparation, Submission and Follow-up of Marketing Authorisation Renewals, Marketing Authorisation Variations and Transfers of Marketing Authorisation Holders.

 

Technical and scientific support 

  • MA Dossier Gap Analysis;

  • Review of module 3 – Quality;

  • Preparation of sub-module 2.3 – Quality Overall Summary;

  • Elaboration and/or review of Summary of Product Characteristics (SmPC), Patient Information Leaflet (PIL) and Labelling texts;

  • Update of QRD (Quality Review of Documents) template of SmPC, PIL and Labelling texts;

  • Elaboration and/or review of SmPC, PIL and Labelling mock-ups;

  • Preparation of Readability Tests and Bridging Reports;

  • Others. 

 

Medical Devices

  • Market placement support;

  • Elaboration and/or review of technical documents;

  • Elaboration and/or review of label and instructions of use;

  • Compliance with the applicable norms and guidelines;

  • Registration/notification to the Competent Authorities;

  • Monitoring and Market Surveillance;

  • Person Responsible for Regulatory Compliance;

  • Responsible Person.

 

Cosmetics

  • Market placement support;

  • Elaboration and/or review of PIF and RAS;

  • Elaboration and/or review of label and instructions of use;

  • Compliance with the applicable norms and guidelines;

  • Notification to the Competent Authorities;

  • Monitoring and Market Surveillance;

  • Responsible Technician.

 

Food Supplements

  • Market placement support;

  • Elaboration and/or review of label and instructions of use;

  • Compliance with the applicable norms and guidelines;

  • Notification to the Competent Authorities;

  • Monitoring and Market Surveillance.

 

Liaison with Competent Authorities 

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