Blog
Why is pharmacovigilance needed in your company?
30 June 2021
If you run a pharmaceutical company with the investigational or authorised medicinal products you must have heard about pharmacovigilance (PV). As legal obligation is imposed on any Marketing Authorisation Holder (MAH), continuous actions of pharmacovigilance process are required to ensure products’ safety. So why is pharmacovigilance process so important and how can we help you? Pharmacovigilance is a key element of drug lifecycle Indeed it is, since Pharmacovigilance activities are required […]
Are nitrosamine impurities still a concern for a drug product?
18 June 2021
In June 2018 it was recognized that some active substances used in manufacturing of medicinal product contained undesired levels of potentially carcinogenic nitrosamine impurities (e.g. NDMA, NDEA). Immediately afterwards, EU regulators started to establish ways of minimizing that risk. As a result, MAHs were requested to review their manufacturing process and evaluate the risk of the presence and possible sources and formation of nitrosamine impurities in their medicinal […]