NiaClinical Pharma (NCP) is a provider of Pharmacovigilance and drug safety services, including Aggregate reports, a Medical information Contact center, Regulatory affairs, Medical writing, Quality assurance, and a robust Quality Management System. We also offer technology services such as safety database configuration, hosting, and validation, all with a strong commitment to improving health in partnership with our clients.
As a specialized Site Management Organization (SMO), we support clinical trials conducted by pharmaceutical companies, biotechnology firms, and Contract Research Organizations (CROs). Our expertise includes managing clinical research sites, which encompass hospitals and other healthcare institutions that are well-equipped to conduct clinical studies.
With increasing drug costs and stringent regulatory requirements, the complexity of global, end-to-end Pharmacovigilance systems is rising. Marketing authorisation holders are expected to adopt a proactive pharmacovigilance strategy as they seek market approvals for their products in the European Union (EU), United Kingdom (UK), and United States of America (USA). Even semi-regulated markets have now started requesting MAH to establish pharmacovigilance systems.
Regulatory authorities have strict Pharmacovigilance requirements, including electronic submissions of ICSRs, PSURs/PADERs, signal management processes, establishment and evaluation of risk management systems, and the effectiveness of risk minimization. They also demand effective processes to monitor the performance and effectiveness of a pharmacovigilance system and its quality management system, along with the maintenance of the pharmacovigilance system master file (PSMF).
Companies must also appoint an appropriately qualified person responsible for pharmacovigilance (QPPV), and some authorities require the nomination of a local QPPV.
To establish pharmacovigilance processes globally, it is essential to have a robust framework that ensures the safety and monitoring of pharmaceutical products. This framework should be tailored to meet the specific needs and resources of each country or region while adhering to international standards and guidelines.
Our pharmacovigilance team, composed of healthcare professionals and physicians, supports our clients in maintaining a comprehensive Pharmacovigilance system, ensuring it aligns with quality management system requirements.
NCP has established delivery centers in India (Ahmedabad), Europe (Romania), and the United Kingdom (UK).
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