Regulatory Services

Marketing authorisations for medicinal products are subject to very strict overall requirements.

Our Regulatory Affairs team is highly experienced in preparing and maintaining registration documentation for numerous countries all over the world according to the specific requirements of the EU, the CIS, the FDA or national legislation.

We carry out the maintenance of marketing authorisation documents ensuring the right balance of accuracy and efficiency, instantly adapting to changing circumstances, providing quick and pragmatic regulatory/commercial decisions. Our experienced regulatory affairs specialists provide advice, prepare dossiers and keep them up-to-date at all times.

Our services:

  • Maintenance of marketing authorisation dossiers for human medicinal products (CTD modules 1 to 5) and nutritional supplements
  • Planning, preparing, updating and reformatting quality dossiers
  • Compilation of expert reports
  • Preparation of packaging and product information texts
  • Communication with regulatory authorities
  • Monitoring of deadlines
  • Handling deficiency letters; Variations
  • Reformatting CTD > eCTD

Contacts:
Anna Hinica
Head of Regulatory Affairs
Phone: (+ 371) 67 013 723
E-mail: ahinica@olainfarm.lv

JelenaRegulatory Services