Regulatory Affairs and Pharmacovigilance


Entrust experienced professionals to supervise the procedures for adverse drug reactions

In cooperation with our sister company APC Instytut, we provide professional services in the field of Pharmacovigilance (PV, PhV, PVG) tailored to the needs of the marketing authorization holder. WHO defines Pharmacovigilance as “research and activities related to the detection, evaluation, understanding and prevention of adverse reactions or other problems that are related to medicines”.

APC Instytut offers an outsourcing service in the field of pharmacovigilance to those Marketing Authorization Holders (MAH) who want to comply with the legal requirements of the European Union (Regulations 1235/2010, 520/2012 and Directive 2010/84/EC), but have limited resources or do not plan to having a Pharmacovigilance department in the structures of your own company.

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How does it work?

Reduce the regulatory burden by continuously overseeing the updating of legal requirements by APC

Thanks to an experienced team of regulatory specialists, we are able to offer the following services

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Our other services:

Marketing and product management

Support at every stage of the product life

Trade and distribution

Effective management of cooperation in distribution channels, i.e. pharmaceutical wholesalers, pharmacy chains, independent pharmacies

Sales Force Outsourcing

Support your actions with the best sales force

Training and recruitment

Generate lower costs than recruitment and selection conducted in the company