Our Services
We offer a comprehensive range of pharmacovigilance and clinical safety services to ensure compliance with regulatory requirements and enhance patient safety.
Safety Reports Management
Efficient management of safety reports to ensure timely and accurate reporting in accordance with industry standards and regulatory requirements.
Literature Monitoring
Continuous monitoring of scientific literature to identify and evaluate safety information relevant to your products as per regulatory requirements.
Clinical Trials Plans Writings
Expert assistance in drafting clinical trial plans that meet regulatory standards and optimize trial outcomes.
Risk Management Plan Development
Creating comprehensive strategies to identify, assess, and mitigate potential risks associated with pharmaceutical products.
PSUR/DSUR Writing
Preparation of Periodic Safety Update Reports (PSURs) and Development
Safety Update Reports (DSURs) to meet regulatory requirements.
SOPs, WIs, and SDEAs Review and Development
Development, review of Standard Operating Procedures (SOPs), Work Instructions (WIs),Safety Data Exchange Agreements (SDEAs) to ensure compliance .
Trainings and Workshops
Tailored training programs and workshops to equip your team with the latest knowledge and skills in patient safety.
Audit and Inspection Readiness
Comprehensive assessment of your pharmacovigilance system to identify gaps and recommend improvements and offer tailored AI solutions.
