PRAXIGENT Goal:
"PRAXIGENT: Simplifying Drug Safety, Empowering Innovation."
Pharmacovigilance System Setup & Management:
We design and implement robust pharmacovigilance systems that ensure your compliance with global regulatory requirements from the FDA, ICH, and other agencies.is a critical tool used by regulatory authorities, healthcare professionals, and pharmaceutical companies to collect, monitor, and analyze reports of adverse events related to the use of medications, vaccines, and medical devices. These systems help identify potential safety concerns, assess risks, and ensure that products remain safe for public use. By tracking patterns of adverse events, the system supports timely regulatory decisions and promotes public health by enabling quicker responses to emerging safety issues.
Adverse Event Reporting & Case Management:
We offer specialized support in managing and reporting adverse events related to drugs, vaccines, and medical devices. These services help pharmaceutical companies and healthcare providers comply with regulatory requirements by collecting, documenting, and submitting reports of adverse events to authorities like the FDA and EMA. They ensure accurate and timely reporting, risk assessment, and data analysis to maintain patient safety, meet regulatory standards, and support the ongoing monitoring of product safety throughout its lifecycle.
Post Marketing Surveillance:
PRAXIGENT's Post Market Surveillance (PMS) Program is designed to ensure the ongoing safety and effectiveness of pharmaceutical products and medical devices once they are on the market. Our PMS program proactively monitors product performance by collecting, analyzing, and reporting real-world data on adverse events, product complaints, and regulatory updates. By adhering to both FDA and ICH guidelines, we ensure that safety signals are detected early, risks are mitigated, and compliance with global regulatory standards is maintained. Through our expert-driven approach, we help companies continuously improve patient outcomes while meeting stringent post-market regulatory requirements.
Advance Data Analytics:
PRAXIGENT's Advanced Pharmacovigilance Data Analytics solution leverages cutting-edge technology and analytical tools to enhance the monitoring and evaluation of drug safety data. By utilizing advanced algorithms, machine learning, and real-time data processing, this solution enables pharmaceutical companies to identify safety signals, trends, and potential risks more quickly and accurately. It offers in-depth insights into adverse event patterns, ensuring proactive risk management and compliance with regulatory requirements. PRAXIGENT’s solution empowers organizations to make data-driven decisions, optimize safety reporting processes, and improve patient safety outcomes, ensuring a more efficient and reliable pharmacovigilance strategy.
Training and SOP for Staff/Users:
PRAXIGENT’s Pharmacovigilance Training and SOP for Business Users provides tailored educational programs and clear operational guidelines to ensure that business teams are well-versed in pharmacovigilance processes and compliance requirements. These training sessions are designed to equip users with the knowledge needed to manage adverse event reporting, safety data handling, and regulatory submissions effectively. The service also includes the development of customized SOPs that align with global regulatory standards, helping organizations maintain consistent procedures and stay audit-ready. This offering supports smoother operations and fosters a culture of compliance and safety within the company. Also provide Training on safe use of therapies enhancing patient interaction and satisfaction. Ensuring treatments align with health regulations including Proper usage of diagnostic tools and devices.
Industry Trusted....
PRAXIGENT Consultant worked with some of the world's top 10 pharmaceutical companies, delivering proven expertise in pharmacovigilance and regulatory compliance. Our team has collaborated with industry leaders to streamline their drug safety processes, ensuring seamless adherence to global regulations, including FDA and ICH standards. By leveraging cutting-edge technology and deep industry knowledge, we have successfully managed complex safety monitoring and risk management initiatives for some of the largest pharmaceutical brands. This experience enables us to offer tailored solutions that meet the highest industry standards, empowering companies to maintain compliance while focusing on innovation and patient safety.
© Copyright. All rights reserved.
We need your consent to load the translations
We use a third-party service to translate the website content that may collect data about your activity. Please review the details in the privacy policy and accept the service to view the translations.