JSC SVEIKUVA is providing pharma industry regulatory affairs consulting, pharmacovigilance and risk management services for obtaining and maintaining medicines marketing authorisations in Baltic States (Lithuania, Latvia and Estonia)
|Key people|| Stanislovas Kasparavicius M.Sc. (Pharm.)
Kristina Dabuleviciute Administrator
Ana Petrilovskaja M.Sc. Regulatory Affairs / Pharmacovigilance Manager
Sveikuva provides broad spectrum of pharma regulatory, pharmacovigilance services. Including, regulatory submissions, coordination of procedures and processes, medical writings for generics products, package leaflet user testing for readability, EU e-CTD/NeeS format dossiers publishing, artwork development, temporary assistance services etc.
Sveikuva is family owned regulatory/pharmacovigilance consulting company based in Lithuania. Sveikuva is providing services to the companies in EU and CIS countries since 2003.
Sveikuva gained experience with range of companies from big pharma companies to small marketing authorisation holders with few products. For big pharma we usually provide assistance services, for mid size pharma companies - local regulatory/pharmacovigilance manages with access to various internal computer systems services, while for small companies - we athey fully assuring regulatory and/or pharmacovigilance activities.
Regulatory Affairs services, Pharmacovigilance services, eCTD publishing, and Package leaflet user testing for readability Pharmacovigilance
Pharmacovigilance (PhV) is the science of collecting, monitoring, researching, assessing and evaluating information from healthcare providers and patients on the adverse effects of medicines, biological products, herbals and traditional medicines with a view to:
- Identifying information about potential new hazards.
- Preventing harm to patients.
In EU the pharmacovigilance is regulated by the European Parliament and European Council Regulation (EU) No 1235/2010 and Directive 2010/84/EU, accompanied by the implementing regulation Commission implementing regulation No 520/2012.
JSC Sveikuva provides range of post-marketing pharmacovigilance (PhV), medicines or drug safety services for marketing authorisation holders:
If you are looking for local pharmacovigilance services in Lithuania, Latvia and Estonia:
We are ready to:
- Act as local contact persons for authorities
- Perfom local literature screening for adverse events (or any source of information about your medicines)
- Perform local personnel pharmacovigilance trainings
- Process suspected adverse reactions (ARs) (collection, translation and forwarding of the information, follow-up)
If you are looking for general post-marketing PhV support:
We are ready to:
- Appoint QPPV (Qualified Person Responsible for Pharmacovigilance)
- Register your company in EudraVigilance
- Provide management of pharmacovigilance data
- Process of case data
- Prepare adverse reaction reports
- Perform adverse events / reactions reporting to competent authorities
- Enter data to EudraVigilance
- Perform literature screening (world wide and local)
- Prepare periodic safety update reports (PSURs)
- Prepare RMPs (Risk Management Plans, corresponding to GVP)
- Evaluate safety data
- Prepare of reference safety information
- Perform regulatory submissions