• 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:

• 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.