VIGILANCE SERVICES
End-to-End Vigilance
We ensure the continuous monitoring, evaluation, and reporting of safety information across the entire product lifecycle, from pre-market assessments to post-market surveillance, to safeguard public health and ensure regulatory compliance.
Pharmacovigilance System Master File (PSMF) Services
We offer specialized services for compiling, reviewing, and maintaining the Pharmacovigilance System Master File (PSMF) for all Marketing Authorization Applications (MAAs) and Marketing Authorization Holders (MAHs). Our comprehensive approach ensures that your PSMF is meticulously prepared and kept up-to-date, reflecting the current standards and regulatory requirements for pharmacovigilance.
Our expert team handles the compilation of detailed documentation that outlines your pharmacovigilance system, including processes for monitoring, assessing, and managing drug safety. We review and update the PSMF regularly to incorporate the latest information on adverse event reporting, risk assessment, and safety signal detection. Additionally, we ensure that the roles and responsibilities of your pharmacovigilance personnel are clearly defined and compliant with regulatory guidelines.
By entrusting us with your PSMF management, you can confidently demonstrate your commitment to drug safety and regulatory compliance, facilitating seamless interactions with regulatory authorities and supporting the ongoing safety and efficacy of your products in the market.
Expectations
✓ Comprehensive PSMF Authoring
✓ Regular Reviews and Updates
✓ Annex Maintenance and Preparation
Expectations
✓ Establishment and maintenance of the MAH’s PV system.
✓ 24/7 availability of the PV point of contact for RAs.
✓ Monitoring product safety and emerging concerns.
✓ Oversight of the PV system’s functioning and quality.
Qualified Person for PV (QPPV)/Local Responsible Person
As your Qualified Person Responsible for Pharmacovigilance (QPPV), Local Contact Person for Pharmacovigilance (LCPPV), or Local Safety Officer (LSO), we provide tailored services to address your specific regional pharmacovigilance needs. Our expert team is dedicated to ensuring that your pharmacovigilance system operates effectively and complies with all relevant regulatory requirements across different regions.
We handle the full spectrum of pharmacovigilance responsibilities, including the oversight of adverse event reporting, risk assessment, and safety signal detection. Our services include maintaining detailed records, managing safety reports, and facilitating communication with regulatory authorities to ensure timely and accurate submissions.
By partnering with us, you benefit from our deep understanding of local and international regulations, which allows us to offer strategic guidance and support. This ensures that your products remain compliant with regional regulations while safeguarding patient safety and supporting your business goals.
24/7 Support
Our dedicated team is available to ensure compliance with regulations.
Safety Database
Ensure compliance and streamline your safety data management with our advanced Safety Database, designed to enhance your pharmacovigilance activities. Our Safety Database provides robust real-time monitoring capabilities, enabling you to track and analyze safety data as it is reported. This ensures that you can promptly identify and address potential safety issues, facilitating proactive risk management and timely regulatory reporting.
Our system features secure data storage, safeguarding your sensitive safety information with the highest standards of data protection and confidentiality. With comprehensive reporting tools, you can generate detailed safety reports and summaries that meet regulatory requirements and support informed decision-making. Our Safety Database is designed to support optimal pharmacovigilance practices by integrating seamlessly with your existing processes and providing actionable insights into safety trends and emerging signals.
By utilizing our Safety Database, you benefit from a streamlined, efficient approach to safety data management, enhancing both regulatory compliance and overall safety performance.
Expectations
✓ Secure data storage
✓ Data analytics and trend analysis
✓ Compliance with regulatory standards
Expectations
✓Comprehensive Medical Writing
✓ Comprehensive Data Analysis
✓ Risk-Benefit Assessment
Aggregate Reporting
We ensure that safety data from a variety of sources is meticulously collected, analyzed, and reported in a comprehensive manner. Our process involves aggregating safety information from clinical trials, post-market surveillance, and other relevant data sources to provide a complete picture of product safety.
Our expert team conducts thorough analyses to identify potential safety signals and trends that could indicate emerging risks. This proactive approach enables us to assess and evaluate the risk-benefit profiles of your products, ensuring that any potential issues are addressed promptly and effectively.
Additionally, our comprehensive reporting is designed to meet stringent regulatory requirements, providing detailed and accurate submissions that facilitate smooth interactions with health authorities. By maintaining high standards in data collection and analysis, we support your commitment to patient safety and regulatory compliance, helping you navigate the complexities of pharmacovigilance with confidence and efficiency.
Report Types
- PSURs
- PBRERs
- Safety Assessment Reports.
Risk management
We specialize in managing the entire risk management lifecycle, providing expert services that cover every stage from initial planning through to implementation and ongoing evaluation. Our comprehensive approach includes the development and execution of robust Risk Management Plans (RMPs) and Risk Evaluation and Mitigation Strategies (REMS) tailored to your specific needs and regulatory requirements.
Our team works closely with you to create detailed RMPs that outline strategies for identifying, assessing, and mitigating potential risks associated with your products. We also develop effective REMS that address specific safety concerns and ensure that necessary risk minimization measures are in place.
By implementing these strategies, we help you proactively manage risks, enhance product safety, and maintain compliance with regulatory standards. Our end-to-end risk management services ensure that your products are continually monitored and adjusted as needed, supporting long-term safety and efficacy while facilitating regulatory interactions and approvals.
Expectations
✓ Customization to align with local regulatory requirements.
✓ Meticulous preparation of submissions.
✓ Diligent tracking and assessment processes to ensure the effectiveness of implemented measures.
Expectations
✓ Timely Detection and Assessment
✓ Comprehensive Reporting
✓ Regulatory Compliance
Signal management
We focus on the comprehensive detection, assessment, and prioritization of potential safety signals related to medicinal products. Our process involves systematically monitoring safety data to identify any new risks or changes in known risks associated with your products.
Our expert team employs advanced analytical techniques and tools to thoroughly evaluate safety signals, ensuring that any emerging issues are promptly detected and assessed. By prioritizing these signals based on their potential impact on public health, we facilitate timely and effective interventions to address and mitigate risks.
This proactive approach is crucial for maintaining product safety and complying with regulatory requirements. It ensures that necessary actions are taken swiftly to protect public health and enhance patient safety. Our dedicated efforts help you stay ahead of potential safety concerns, supporting the ongoing success and reliability of your medicinal products in the market.
Key Points
- Comprehensive Monitoring
- Expert Analysis.
- Customized Solutions
Medical coding
We specialize in accurately translating medical terms into standardized codes, a crucial step for effective data analysis and regulatory reporting. This meticulous process involves converting complex medical terminology into universally accepted coding systems, such as MedDRA or WHO-ART, to ensure consistency and accuracy in data interpretation.
Standardized coding is essential for the identification and tracking of adverse events, as it enables precise categorization and detailed reporting of safety information. By applying these standardized codes, we ensure that safety data is systematically organized and communicated effectively to regulatory authorities and other relevant stakeholders.
Our approach supports comprehensive data analysis, facilitating clear communication and reporting that meets regulatory requirements. This process not only enhances the quality and reliability of safety data but also contributes to informed decision-making and improved patient safety. Our expertise ensures that your safety information is accurately and efficiently processed throughout its lifecycle.
Expectations
✓ Accuracy and Consistency
✓ Compliance with Global Standards
✓ Timely Updates
Expectations
✓ Regulatory Compliance
✓ Clarity and Precision
✓ Regular Updates
Product labelling
We ensure that all safety information, usage instructions, and regulatory requirements are meticulously reflected on product labels, a critical aspect of product management. Our comprehensive labeling process involves thorough reviews and updates to ensure that every detail on the label is accurate, clear, and compliant with both local and international regulations.
This process includes verifying that all safety warnings, dosage instructions, and usage guidelines are presented in a way that is easily understood by consumers. We also ensure that the labeling meets the specific requirements set forth by regulatory authorities in various regions, addressing any differences in regulatory standards and compliance expectations.
By maintaining high standards in labeling, we help protect consumers by providing them with essential information needed for the safe and effective use of products. Our approach supports regulatory compliance and contributes to the overall safety and success of your products in the marketplace.
Regulatory Intelligence
We proactively gather, analyze, and apply comprehensive regulatory information to ensure your products remain in compliance and to optimize safety strategies throughout their lifecycle. Our dedicated team continuously monitors and reviews updates from regulatory agencies and industry standards to keep you informed of any changes that could impact your products.
By analyzing this regulatory information, we identify potential compliance issues and recommend strategic adjustments to enhance your product’s safety and regulatory standing. This proactive approach helps companies stay ahead of regulatory changes, minimizing risks and avoiding potential disruptions.
Our service provides valuable insights and actionable recommendations that support informed decision-making at every stage of the product lifecycle, from development through post-market activities. By integrating up-to-date regulatory information into your safety strategies, we help you navigate complex regulatory environments efficiently, ensuring sustained compliance and product success in the marketplace.
Expectations
✓ Proactive Monitoring
✓ Informed Decision-Making
✓ Tailored Strategies
Expectations
✓ Real-World Data Collection
✓ Regulatory Compliance
✓ Risk Mitigation
Post-authorisation safety studies (PASS)
We monitor the safety and effectiveness of products even after they have been authorized for market use, a critical component of post-market surveillance. Our comprehensive approach involves conducting detailed studies and ongoing assessments to track product performance and identify any potential risks that may not have been apparent during pre-market trials.
These post-market studies are essential for detecting adverse events, unforeseen side effects, or changes in product efficacy that could emerge once the product is used by a broader population. By systematically collecting and analyzing real-world data, we ensure that any new safety concerns or effectiveness issues are promptly identified and addressed.
Our proactive monitoring efforts help maintain high standards of product safety, compliance, and effectiveness throughout the product lifecycle. This continuous vigilance supports regulatory requirements and provides reassurance to consumers, contributing to the overall success and reliability of your products in the market.
Patient Support Program/Non-Interventional Program
We provide continuous assistance and monitoring for patients using a product, while ensuring that their standard medical care remains unchanged. Our patient support programs are designed to enhance safety and optimize health outcomes by gathering valuable real-world data and offering guidance without disrupting existing treatment protocols.
These programs focus on closely monitoring patient experiences and adherence to treatment regimens, allowing us to identify any issues or challenges that may arise during product use. By collecting and analyzing this data, we gain insights into how the product performs in everyday clinical settings, which helps in identifying potential areas for improvement or additional support.
Our approach not only improves patient adherence and safety but also contributes to better overall health outcomes by ensuring that patients receive the most effective and appropriate care. Through ongoing engagement and support, we help bridge the gap between clinical trials and real-world application, fostering a more effective and patient-centered approach to treatment.
Expectations
✓ Real-World Data Collection
✓ Patient-Centered Support
✓ Compliance and Reporting
Expectations
✓ Robust Quality System
✓ Quality Adherence
✓ Quality Control and Assurance
✓ Quality Improvements
Quality System
Intricate structures, processes, and outcomes, serving essential functions within the vigilance framework.
Quality Planning
Establish coherent structures and integrated processes tailored to the specific vigilance requirements.
Quality Adherence
Implement tasks and responsibilities in strict accordance with established quality standards.
Quality Control and Assurance
Regular monitoring and evaluation of the effectiveness of established structures and processes.
Quality Improvements
Address corrective actions and implement improvements to enhance the overall quality system.
Vendor management and Marketing Authorisation Holder (MAH) oversight
We ensure that all partners and vendors involved in the product lifecycle adhere strictly to regulatory requirements, which is crucial for maintaining the integrity and compliance of your products. Our comprehensive oversight processes include rigorous evaluations and continuous monitoring of all external parties to ensure they meet or exceed necessary standards and guidelines.
Simultaneously, we support the Marketing Authorization Holder (MAH) in maintaining full control and accountability over product safety and compliance. Our services involve coordinating closely with the MAH to manage and oversee all aspects of regulatory compliance, from initial development through to post-market activities.
This approach ensures that the MAH is fully informed and able to make strategic decisions based on up-to-date compliance information. By keeping all partners aligned with regulatory requirements, we help mitigate risks, prevent compliance issues, and support the overall success and safety of your product throughout its entire lifecycle.
Expectations
✓ Regulatory Compliance Monitoring
✓ Centralized Accountability
✓ Risk Mitigation
Expectations
✓ Comprehensive Assessments
✓ Gap Analysis and Remediation
✓ Regulatory Readiness
Audits and Inspections
We ensure that all processes and systems related to product safety and regulatory compliance undergo thorough evaluations to confirm that they meet the required standards. Our comprehensive service includes a detailed assessment of your operational procedures, safety management systems, and regulatory documentation to ensure full compliance with industry regulations and guidelines.
Through our meticulous evaluations, we identify potential gaps or weaknesses in your safety and compliance frameworks. This proactive approach allows us to address any issues before they become problematic, helping to mitigate risks associated with regulatory non-compliance and safety concerns.
By preparing your company for regulatory scrutiny, we support you in achieving and maintaining high standards of product safety and compliance. Our service not only ensures that you are well-prepared for audits and inspections but also enhances your ability to respond effectively to any regulatory challenges that may arise, thereby safeguarding your product’s market success.