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
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.
• 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.
Regulatory affairs manager
Tel. +38 (095) 294 27 06