Pharmacovigilance Training System (FVG), Technovigilance (TVG):

We offer a comprehensive pharmacovigilance/technovigilance training system tailored to your organization’s needs. Delivered on a per-requirement basis, our programs can be scaled to train the entire company or specific teams, with pricing adjusted to the number of employees.

Our service includes the development of standard operating procedures (SOPs), customized training plans, and complete training record packages. We design professional, interactive learning materials such as high-quality videos, e-learning modules, digital workbooks, and competency assessments to ensure knowledge retention and regulatory compliance. This end-to-end approach equips your staff with the skills required for effective pharmacovigilance and strengthens your organization’s inspection readiness.

Pharmacovigilance Support Services

We offer a comprehensive suite of pharmacovigilance support services to strengthen regulatory compliance and risk management:

• Literature Search
  Regular monitoring of adverse events related to your products or active ingredients using scientific databases such as Scielo, Lilacs, and ANMAT updates. Delivered weekly or monthly to ensure continuous surveillance.
• Adverse Event Monitoring on Social Media
  Ongoing analysis of your company’s social media channels to identify potential adverse events. Weekly reports provide documented evidence for audits and inspections. Any confirmed case is processed according to regulatory requirements.
• Pharmacovigilance Documentation
  Development of essential pharmacovigilance documentation offered as individual items or bundled packages — including SOPs, Site Master Files for pharmacovigilance, and supporting materials for national or international audits.

This integrated approach provides timely intelligence, robust documentation, and full readiness for inspections, enhancing the safety and compliance profile of your organization.

Case Processing – Adverse Event Reporting:

We provide comprehensive case processing services for adverse events using industry-standard e-Reporting platforms. This complex service requires continuous vigilance from our team and includes reporting cases to the Uppsala Monitoring Centre (WHO Programme for International Drug Monitoring) through the e-Reporting system, completing case forms, archiving records, performing follow-up activities, and ensuring proper case closure.

If your company operates under a licensing agreement, we also handle the reporting to the licensor for submission to the corresponding foreign health authority. Our robust processes guarantee data integrity, timely submissions, and full compliance with national and international pharmacovigilance requirements.