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.
- +48 693 415 413
- office@apcpharmlog.eu
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
- Submission, monitoring and finalization of the registration process for medicinal products, medical devices, biocidal products, dermocosmetics and dietary supplements
- Acting as MAH on behalf of the Client for procedural purposes
- Translation and adaptation to the requirements of Polish health authorities: PIL, SmPC / biocidal product characteristics, mock-ups, packaging information
- License maintenance (changes, renewals)
- Pharmacovigilance
- Patient leaflet testing by users
- Reformatting paper documentation into electronic (eCTD, NeeS)
- EU Regulatory Services (APC is a member of EuDRAcon - European Regulatory Consultancy Network, www.eudracon.com )
