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:
There are two types of service models that your company can choose from:
Medical Writing FSP Model: Our team will take the responsibility of managing all medical writing activities for a complete clinical program or for an individual study with a cost-effective pricing structure.
Dedicated Resoucing Model: We can have specialized resources allocated for your organization to hand-hold all types of medical writing needs for a fixed duration.
We use the best of technology platforms that helps us to deliver our medical writing services through continous real-time collaboration with sponsors. Following are some of the systems we use:
Compier Medical Writing Platform: This is our proprietary 100% digital content management platform that facilitates rapid content authoring, completing real-time collaborative review and allows continous content lifecycle management. specifically for rapidly processing soft such as Microsoft Word to create documents.
Reference management software: Our Medical writers use reference management software such as EndNote, Mendeley, or Zotero to manage and organize their references.
Content management systems: If sponsors want us to use content management systems (CMS) like Veeva Vault, Documentum or Sharepoint, our team is familar with how to store and manage documents, track versions, and facilitate collaboration between different team members.
Typesetting software: Medical writers use typesetting software such as LaTeX or InDesign to create well-formatted documents, such as scientific publications and regulatory documents.
Medical Terminology software: Medical writers use medical terminology software such as SNOMED, ICD-10, or MedDRA to ensure accurate and consistent use of medical terms.
With the use of advanced technology and quality-driven processes, our medical writing team members collaborate with Biostatistics, Medical Affairs, Drug Safety and Clinical Data Management teams to deliver accurate and purposeful publications and other medical content with a quick turnaround with 100% compliance to global regulatory requirements. Every medical writing project is meticulously managed and delivered with stringent scientific, statistical, editorial and quality control review.