PHARMACOVIGILANCE AND RISK MANAGEMENT SERVICES
At CureEon, we understand the critical importance of drug safety and the role it plays in the pharmaceutical, biotech, and medical device industries.
Our pharmacovigilance services are designed to ensure the safety and efficacy of your products, while also meeting regulatory requirements.
OUR PHARMACOVIGILANCE SERVICES
CureEon offers a comprehensive range of pharmacovigilance services to help you manage the safety of your pharmaceutical and medical products. Our services include:
ADVERSE EVENT
REPORTING
We assist in the collection, assessment, and reporting of adverse events associated with your products. Timely and accurate reporting is crucial to regulatory compliance.
AGGREGATE
REPORTS
Our team compiles and submits regulatory reports (DSURs, PSURs, PADERs, etc.) to regulatory authorities to provide updates on the safety of your products.
SIGNAL
DETECTION
We employ advanced signal detection methods to identify potential safety issues and emerging trends related to your products.
REGULATORY
RESPONSES
We have supported hundreds of regulatory response submissions, and can develop the strategy for the response and help draft the regulatory response.
PHARMACOVIGILANCE INSPECTIONS AND AUDITS
We help you prepare for pharmacovigilance inspections and audits to ensure compliance with regulatory requirements.
REGULATORY
SUBMISSIONS
We have supported many successful regulatory submissions, including INDs, NDAs, PMAs, CTDs, etc. We can also help to prepare for FDA Panel Meetings.
OUR RISK MANAGEMENT SERVICES
In the highly regulated pharmaceutical, biotech, and medical device industries, managing and mitigating risks are crucial to ensuring the safety and success of your products. At CureEon, we provide expert risk management solutions to help you navigate these challenges. CureEon offers a range of comprehensive risk management services designed to safeguard your products and meet regulatory requirements. Our services include:
RISK
ASSESSMENT
Our experienced team conducts thorough risk assessments to identify potential hazards and develop strategies for risk mitigation.
RISK MANAGEMENT
PLANS
We help strategize, plan and implement Risk Management Plans (RMPs), including support for REMS programs.
RISK DOCUMENTATION
AND REPORTING
Our team ensures comprehensive documentation of risk management activities and reporting to regulatory authorities as required.
RISK MONITORING AND SURVEILLANCE
We implement continuous risk monitoring and surveillance systems to detect and respond to emerging safety issues.
RISK
COMMUNICATION
Effective communication is vital. We help you communicate safety information to healthcare professionals and patients, ensuring they are informed about potential risks.
RISK MINIMIZATION
STRATEGIES
We assist in the development and implementation of risk minimization strategies to ensure the safety and efficacy of your products.
BENEFIT RISK
ASSESSMENT
We perform benefit risk assessments to evaluate the overall balance between the benefits and risks of your products, providing valuable insights for decision - making.
CONTACT US
Whether you're seeking support for your clinical research, pharmacovigilance, or regulatory approval needs, CureEon is here to assist you.
