Audits & Inspections Support

• Preparing for regulatory audits and inspections (e.g., MHRA, FDA, EMA).
• Conducting internal audits to ensure compliance with Good Pharmacovigilance Practices (GVP).

Pharmacovigilance System Master File (PSMF)

• Creation and maintenance of PSMF as per EU regulations.
• Regular updates to ensure compliance with evolving regulatory guidelines.

Aggregate Reporting

Preparation of periodic safety reports, including:

• Periodic Safety Update Reports (PSURs)
• Periodic Benefit-Risk Evaluation Reports (PBRERs)
• Development Safety Update Reports (DSURs)
• Annual reports for investigational drugs
• Risk-benefit evaluation and recommendations for risk mitigation

Risk Management Plan (RMP) Development

• Development and review of RMPs tailored to the drug profile
• Ensuring effective risk minimization measures

Case Processing & Safety Data Management

• Receipt, triage, and processing of Individual Case Safety Reports (ICSRs).
• Data entry, narrative writing, medical coding (using MedDRA/WHO-DD), and seriousness assessment.

Safety Database Setup & Maintenance

Our services extend beyond approval with:

• Setting up and configuring safety databases compliant with global regulatory standards (e.g., EudraVigilance, FDA).
• Continuous monitoring, optimization, and troubleshooting of the database to maintain smooth operations.
• Ensuring timely reporting to regulatory authorities and business partners.

Medical Information System

• Providing scientific and medical support for queries from healthcare professionals and consumers.
• Maintaining accurate documentation of medical inquiries.

Regulatory Submissions

• Submission of adverse event reports (e.g., SUSARs, expedited reports).
• Managing submissions through regulatory portals like EudraVigilance, FDA’s FAERS, and others.

Safety Data Exchange Agreements (SDEAs)

Our services extend beyond approval with:

• Drafting and managing safety data exchange agreements with business partners.
• Defining roles and responsibilities for pharmacovigilance activities.

Literature Monitoring

• Conducting systematic reviews of scientific literature for adverse event detection.
• Identifying safety signals from published data.

Pharmaceutical, Ayurveda & Medical Devices Pharmacovigilance

• Specialized services for monitoring and managing adverse events related to Pharmaceutical, Ayurveda and medical device products.
• Aligning processes with regional and global guidelines for medicines and devices.

Safety Database Setup & Maintenance

Our services extend beyond approval with:

• Setting up and configuring safety databases compliant with global regulatory standards (e.g., EudraVigilance, FDA).
• Continuous monitoring, optimization, and troubleshooting of the database to maintain smooth operations.
• Ensuring timely reporting to regulatory authorities and business partners.