Pharmacovigilance is the process of monitoring, recognizing, evaluating, and preventing adverse drug reactions and any other drug-related problems from healthcare providers and patients. Pharmacovigilance is crucial for detecting, evaluating, understanding, and preventing adverse drug reactions, especially long-term and short-term side effects of drugs.
Purpose of Pharmacovigilance
- Prevent patient harm from medicines
- Detect adverse reactions and interactions with unknown medicines
- Identify increasing trends in known adverse drug reactions
- Analyze risk factors and possible mechanisms for adverse drug reactions
- Facilitate drug supervision and management and guide the clinical use of drugs
Our Services
Pharmacovigilance is essential to ensure the safety of drugs, especially in the field of generics, which are required to demonstrate consistency in safety, quality and efficacy with the RLDs. As a reliable provider of generic consistency assessment services, Alfa Chemistry offers a wide range of flexible, cost-effective and scalable pharmacovigilance services.
Pharmacovigilance Compliance Consulting
We provide specialized regulatory compliance consulting services to help clients understand and comply with pharmacovigilance regulations in different countries and regions.
Pharmacovigilance Training
We provide pharmacovigilance-related training services to help pharmaceutical companies and healthcare professionals improve their understanding and ability to handle drug safety issues.
Data Collection and Management
We provide data collection services on adverse drug reactions from various sources, including patient reports, reports from healthcare professionals and information in the literature, and assist clients with statistical analysis of the collected adverse drug reactions.
Case Safety Report Management
We collect pre-market and post-market case safety reports, fully assess their severity and relevance, and ensure that our clients can respond in a timely manner and take appropriate follow-up actions.
Report Preparation
We assist our clients in the preparation and submission of all necessary pharmacovigilance reports based on the data collected and evaluated. We ensure that the reports follow the correct format and language requirements, and that they are scrutinized for accuracy and professionalism prior to submission.
Safety Signal Monitoring
Using advanced statistical algorithms, we can identify potential drug safety signals from large volumes of data. We conduct in-depth evaluations of these signals to determine if further investigation or regulatory action is required.
Third-Party Pharmacovigilance Services
We offer comprehensive third-party pharmacovigilance management services, including data collection, report writing and regulatory compliance.
Pharmacovigilance System Support
We help clients design and implement effective pharmacovigilance systems, including drug safety databases, reporting and monitoring processes, to meet the specific needs of different clients.
Pharmacovigilance Information Maintenance
We regularly maintain and update our clients' pharmacovigilance information, including new safety data and regulatory requirements, and ensure that all pharmacovigilance information is secure against data leakage or unauthorized access.
Audit and Inspection Support
We help clients prepare for pharmacovigilance audits and provide on-site support during audits and inspections to enable them to respond to regulatory agency inspections. In addition, we assist our clients in resolving issues identified during the audit and make recommendations for improvement.
Risk Assessment
We assist our clients in conducting risk assessments of drugs to determine the risk-benefit ratio of the drug. We provide risk management plans to help pharmaceutical companies develop strategies to minimize drug risks.
Our Advantages
- Our team consists of highly specialized pharmacy and healthcare professionals
- We have established proprietary and comprehensive pharmacovigilance systems and databases to ensure data accuracy, completeness and traceability.
- Partnering with us saves you time and resources compared to staffing and building your own platform.
- Our compliance services team ensures that your strategy and activities are in line with the requirements of regulatory agencies.
- We provide customized solutions based on our clients' needs, so you can be confident in your pharmacovigilance strategy and compliance activities
Our one-stop pharmacovigilance solution integrates seamlessly into your processes and greatly facilitates your company's increasing pharmacovigilance regulatory obligations.
