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:

PSMF Maintenance

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:

Regular Review

The PSMF should be reviewed regularly, at least once a year, to ensure that it remains up-to-date and reflects any changes in the company's pharmacovigilance system.

Documentation of Changes

Any changes made to the PSMF should be documented and retained for future reference. This documentation should include the date of the change, the reason for the change, and the person responsible for the change.

Updating the PSMF

The PSMF should be updated to reflect any changes to the company's pharmacovigilance system, processes, and procedures. This may include updates to the company's policies, procedures, and training programs.

Regular Audits

Regular internal and external audits should be conducted to ensure the continued compliance of the pharmacovigilance system with the regulatory requirements. The results of these audits should be used to update the PSMF as necessary.

Business Discussion

Supporting Documents

The PSMF should be supported by a range of other documents, including Standard Operating Procedures (SOPs), job descriptions, training materials, and forms. These supporting documents should also be regularly reviewed and updated as necessary.

Service FAQs

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.

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