Careers Media center Contacts

LLC “АRTERIUM LTD” provides comprehensive and professional regulatory affairs and pharmacovigilance services in Ukraine, CIS countries, Georgia, Vietnam, Macedonia, Bosnia and Herzegovina, and Serbia.

WE PROVIDE SERVICES FOR:

 


  • active pharmaceutical ingredients

  • human medicinal products

  • herbal medicinal products

  • veterinary medicinal products

  • medical devices

  • food supplements


 Regulatory Affairs Services:
• marketing authorization of pharmaceutical products;
• development of pharmaceutical product lifecycle management;
• market access strategy development (selection of the procedures for marketing authorization of products);
• target product profile development (specification of the requirements for product development and content of the dossier);
• assessment of the registration dossier;
• compilation of the registration dossier in accordance with local regulatory requirements;
• support of the marketing authorization procedures in regulatory authorities;
• support of WHO prequalification procedure.

 Pharmacoeconomics and Consulting Services:
• preparation of pharmacoeconomics calculations;
• development of application for drugs inclusion to the nationaly formulary systems;
• local regulatory requirements reports preparation (for any country around the globe);
• assessment of drugs evidence base and Market Access Assessment;
• promo materials assessment;
• scientific and regulatory consultations;
• in-house trainings and seminars.

 Pharmacovigilance:
• compliance with guidelines on GVP;
• services of QPPV (24/7) with access to medical adviser;
• establishment and maintenance of the Pharmacovigilance system;
• management and reporting of adverse reactions to medicinal products;
• ongoing risk-benefit evaluation;
• preparation of Risk Management Systems and Risk minimization measures;
• audit of PhV system.

 Medical Affairs and writing services:
• SmPC, PIL and Labelling preparation;
• Periodic Safety Update Report preparation;
• Risk Management Plan preparation.

Compliance with ISO 9001:
Our Quality Management System is certified and complies with the requirements of ISO 9001 standard.

Contact us:
Regulatory affairs manager
Lyn Sofiia
Sofiia.Lyn@arterium.ua
Тел. +38 (050) 370-92-17