REGULATORY AFFAIRS

Our regulatory affairs managers are high class specialists. They are ready to support your regulatory activities in Latvia as well as  in the other Baltic states.
Since the requirements in each country differ, this work should be entrusted to professionals who are familiar with the specific nature of the region and are able to solve problems promptly. We are ready to offer the following services:

Services
Comment
  • Revision of the dossiers prepared by the client, preparation of these documents for registration, renewal and all kinds of variations;
  • Representation of a client’s interests in the Agency;
  • Submission of the dossiers (authorizations/ renewals/ variations, NP, MRP, DCP) to the Agency;
  • Preparation of the labeling text according to the local legislation;
  • Support during approval of the labeling text and mock-ups;
  • Proofreading of printed materials;
  • Preparation of product information according to the latest QRD;
  • Responding to regulatory agency questions, as well as preparation of official letters;
  • Consulting the client regarding all regulatory issues.

 

 

Relevant for:

LATVIA, LITHUANIA, ESTONIA

 

  • Representation of the manufacturer in the Latvian market (we could offer Marketing Authorization Holder services).

May be required in the following cases:

  • New product launch
  • Ready Pharmacovigilance system
  • For manufacturers from non-EU countries
  • MAH transfer can be performed very fast upon request
  • We also conduct Readability User Testing of patient information leaflets (PIL) for our clients. The services we are ready to offer include:
    • Professional PIL user testing based on the latest EU and local legislation;
    • Test questionnaire prepared specially for the tested product;
    • Preparation of mock-ups (before test and with amendments after test);
    • Preparation of an English and Latvian version of the report;
    • Support in following submission to the authorities and further related activities.

 

 

Terms can be specified

by the client.

  • Upon request, we can prepare reconciliation and/or monthly reports.

 

  • We keep our clients informed about all the changes in local legislation.

This is the right way:

  • To be in line with legislation;
  • To be out of problems with competent Authorities;
  • To avoid any delays in regulatory processes.

Please feel free to contact us for further information: ra@snovigroup.com