Regulatory Affairs

MA Holders/ Manufacturers/ Wholesale Distributors

 

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 Procedure, Mutual Recognition Procedure, Decentralised Procedure and Centralised Procedure, in NeeS (Non-eCTD electronic Submission) and eCTD (electronic Common Technical Document) format.

 

Post-authorisation activities  

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

 

Scientific support 

  • Re-structure of MA dossiers from the NTA-format into the CTD-format and consolidation;

  • Review of module 3 – Quality;

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

  • Elaboration, review and translation 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;

  • Other Scientific Documentation, as requested.

     

Point of contact with the Competent Authorities

 

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.

 

Cosmetics

  • 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;

  • Notification to the Competent Authorities;

  • Monitoring and Market Surveillance.

 

Food Supplements

  • 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;

  • Notification to the Competent Authorities;

  • Monitoring and Market Surveillance.

 

Biocidal Products

  • 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;

  • Notification to the Competent Authorities;

  • Monitoring and Market Surveillance.

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