We Are Here To Grow Your Market Share
Pharmacovigilance
EU and national level Qualified Person Responsible for Pharmacovigilance QPPV(s) and/or deputy QPPV including all the obligations and functions laid down in the Good Pharmacovigilance Practices Module, specifying:
Safety profiles monitoring of medicinal products
Timely submissions monitoring
Literature review
Maintaining RSI and PSMF
24 h availability and reporting service
Market Access
Pricing and reimbursement services include:
Market potential assessment for medicinal products and medical devices
Full pharmacoeconomic evaluation
Preparing reimbursement documentation for national Lists of Reimbursed medicines;
Complete impact on budget analysis (models) of the medicinal product
Pricing options for medicinal products
Regular price monitoring of medicinal products
Food & Food Supplements
Full cycle of service or consultations for your food supplements/food for special medical purposes:
Assessment of product compatibility with local notification requirements and recommendations
Preparing and revising label texts according to applicable regulatory requirements, including European Food Safety Agency (EFSA) health claims
Processing of documentation for competent authorities
Representation - submission and further communication with regulatory bodies
Regulatory Affairs
The array of services includes pre-evaluation and consequent registration of medicines, medical devices, food supplements and cosmetics in respective national competent authorities in the Baltics and other EU countries:
Obtaining marketing authorisation for medicinal products (human and veterinary)
Annual updates and safety updates for medicinal products in European Medicines Agency (EMA)
Registration of medical devices in national competent authorities
Notification of food supplements and food for special medical purposes
Notification of cosmetic products (CPNP)
Medical writings (PSURs, RMPs)
Processing of ADRs
Medical Writing and Translation Services
Covering legal, life science, medical, pharmaceutical, biotechnologies, technical and other areas of translation:
Patient leaflet readability testing, including identifying patient groups and elaboration of the testing strategy
Regulatory medical writing (Clinical study protocols, Informed Patient Consent forms, Investigator’s Brochures, Agreements with healthcare institutions and suppliers, Patient diaries etc.)
Localization services
