PSMF Lifecycle Management
The Pharmacovigilance System Master File (PSMF) is a document submitted to the European Medicines Agency (EMA) as part of the pharmacovigilance requirements for marketing authorization of a medicinal product in the European Union (EU). The PSMF provides a comprehensive overview of the company’s pharmacovigilance system and processes, including how adverse event (AE) reports are received, assessed, and processed.
With over 15+ years experience, our medical writing team has helped several pharma and medical device companies by delivering clinical, non-clinical, regulatory, and post-marketing related medical writing services with the following principles:
Services We Offer
At Techsol, our expert team of Medical writers have an extensive research background, scientific knowledge, and ample experience in contributing to clinical development programs for global pharma companies.
Following are the key focus areas where our medical writing team has the expertise to deliver high-quality services throughout the drug / device development lifecycle as per applicable regulatory guidelines:
The maintenance of the Pharmacovigilance System Master File (PSMF) is an ongoing process that involves regular review and updates to ensure its continued relevance and compliance with the regulatory requirements.
It is important to ensure that the PSMF is maintained regularly and effectively, as this helps to ensure the continued safety and well-being of patients who use the company’s products. The PSMF provides an overview of the company’s pharmacovigilance system and processes and is a critical component of the regulatory submission for marketing authorization of a medicinal product.
The following are the key steps involved in maintaining the PSMF: