Regulatory Affairs and Pharmacovigilance

KBM Pharma offers consultation services and support for pharmaceutical industry in following areas:

Regulatory Affairs

Regulatory Applications and Maintenance

  • Preparation and submission of applications for Marketing Authorisation, Renewal and Variation to the Estonian State Agency of Medicines, communication between the State Agency of Medicines and the Applicant
  • Representing the Marketing Authorisation Holder at national level
  • Consulting the Marketing Authorisation Holder regarding local legislation and requirements

Translation and Quality check of Product Information, other medical materials (translations from English to Estonian and from Estonian to English) and artworks

  • Preparation/translation/update of Estonian Product Information and other medical materials (incl. Additional risk minimisation measures) and quality control of medical translations
  • Review of artworks of product information and Additional risk minimisation measures

Pharmacovigilance support on national level

  • Collecting, translating and reporting pharmacovigilance related information (adverse reactions, quality complaints and other special reportable situations), Pharmacovigilance follow-up
  • Preparation and update of Additional risk minimisation measures
  • Literature search (monitoring medical journals), translation of articles

Support on placing following products on the market: food supplements, medical devices, biocides, food for special medicinal purposes

Preparation of applications for reimbursement

 

We tailor our services to meet your specific needs and budget.