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As a regulatory leader, your responsibility doesn’t end with market approval, it begins there. This sentiment echoes across boardrooms and regulatory strategy meetings as post-market surveillance (PMS) becomes a critical…
Regulatory authorities worldwide carry out pharmacovigilance (PV) inspections to ensure that marketing authorization holders (MAHs) and their partners comply with all applicable PV regulations, obligations, and standards. These inspections assess…
Pharmacovigilance plays a critical role in the healthcare industry, ensuring that medicines are safe and effective for the public. As the use of pharmaceuticals continues to increase globally, so does…
In today’s fast-evolving pharmaceutical industry, ensuring drug safety and maintaining regulatory compliance is more crucial than ever. Central to this effort is the role of a Qualified Person for Pharmacovigilance…
Pharmacovigilance and regulatory services are essential pillars of the pharmaceutical industry, especially in the UK, where strict regulatory frameworks ensure drug safety, efficacy, and compliance. With the increasing complexity of…
pharmaceutical development and patient safety, the processing of Individual Case Safety Reports (ICSRs) is crucial. These reports document adverse events or side effects experienced by patients using a specific medication,…
Pharmaceutical industries play a crucial role in public health by developing, manufacturing, and marketing medications that save lives. However, introducing new medicines comes with the responsibility to ensure their safety…
Pharmacovigilance is a critical component of ensuring drug safety and efficacy. For pharmaceutical companies operating in Spain, selecting the right partner for pharmacovigilance services is essential to maintaining compliance with…
The pharmaceutical industry operates within one of the most complex regulatory environments in the world. With constantly evolving laws, guidelines, and standards across different regions, managing regulatory compliance is an…
Pharmacovigilance and regulatory services form the bedrock of Australia’s public health system, ensuring that pharmaceuticals are both safe and effective. As the field of medicine continuously evolves, so too does…