Pharmacovigilance / GVP

NOVA-EastPharm OÜ provides full Post Marketing pharmacovigilance support at a national level, as the default service package without any extra fees.

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More about Pharmacovigilance / GVP

Our expertise ensures optimal compliance with national and international pharmacovigilance regulations fulfilling the requirements of the EU, CIS, and EAEU. We offer the service of Local Persons for Pharmacovigilance (LPPV) and Deputy persons with large knowledge and experience of the industry who are responsible for but not limited to local ADR/ICSR intake, follow-ups, and its submission to National Competent Authorities, regulatory intelligence, liaising with National Competent Authorities and regulation changes monitoring, implementation of risk minimisation measures locally, local literature screening of non-indexed journals published locally, availability 24/7 and other ad hoc activities. Our team makes sure our Partners always stay abreast of all PV requirements in a timely manner.

Report Form for Adverse Reactions / Lack of Efficacy

If you would like to inform us about an undesired event, adverse reaction and/or lack of efficacy when using our products, please fill out the following form.

Other services

Business Development

Business Development is responsible for evaluating and establishing long-term business relationships with potential and existing partners, expanding NOVA-EastPharm OÜ product portfolio though exclusive distribution, private labeling, and other types of cooperation.

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Logistics

NOVA-EastPharm OÜ is responsible for a full range of logistic services such as planning the orders into production, maintaining products availability and providing support for the Sales Department.

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Regulatory support / Registration

Our regulatory team has over 15-year experience in providing regulatory service for legalization of pharmaceuticals and medical devices in Ukraine and CIS countries.

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Quality Control / GDP

The entire quality system of the company and all processes related to the purchase, storage, sale and transportation of medicines are subject to verification by the relevant regulatory authorities.

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