AWINSA Life Sciences
AWINSA Life Sciences is a dedicated team of experienced professionals from the pharmaceutical sector, focused on providing innovative, scalable, and cost-effective solutions in pharmacovigilance, clinical safety, medical writing, medical monitoring, and medical affairs. They support pharmaceutical and biotech companies throughout the drug lifecycle, ensuring compliance and adverse event reporting. Their global team combines therapeutic and clinical knowledge to develop safe drugs, medical devices, vaccines, and advanced therapies.
Industries
Nr. of Employees
small (1-50)
AWINSA Life Sciences
Products
Post Marketing Pharmacovigilance Services
Strategic solutions and operational support for managing post-marketing pharmacovigilance challenges, safety databases, and compliance for marketing authorization holders.
Amalgamation of safety data in global clinical trials
Consolidation of clinical trial safety data from multiple CROs into a centralized safety database to provide robust clinical safety and pharmacovigilance services.
Case processing
Robust team to formulate the ICSR with utmost attention to all nuances and also ensure submission within the stipulated timeframes.
SOP Consulting Services
Development of all pharmacovigilance-related Standard Operating Procedures in accordance with global regulatory requirements to ensure efficiency, quality output, and uniformity of performance.
Risk Management Plan Services
Comprehensive Risk Management Plan (RMP) preparation and continuous safety-benefit assessment services for marketing authorization applications in the EU.
QPPV
Qualified Person for Pharmacovigilance (QPPV) services ensuring services of the highest quality that are cost-effective.
Post Marketing Pharmacovigilance Services
Strategic solutions and operational support for managing post-marketing pharmacovigilance challenges, safety databases, and compliance for marketing authorization holders.
Amalgamation of safety data in global clinical trials
Consolidation of clinical trial safety data from multiple CROs into a centralized safety database to provide robust clinical safety and pharmacovigilance services.
Case processing
Robust team to formulate the ICSR with utmost attention to all nuances and also ensure submission within the stipulated timeframes.
SOP Consulting Services
Development of all pharmacovigilance-related Standard Operating Procedures in accordance with global regulatory requirements to ensure efficiency, quality output, and uniformity of performance.
Risk Management Plan Services
Comprehensive Risk Management Plan (RMP) preparation and continuous safety-benefit assessment services for marketing authorization applications in the EU.
QPPV
Qualified Person for Pharmacovigilance (QPPV) services ensuring services of the highest quality that are cost-effective.
Services
Comprehensive outsourced PV operations including ICSR intake and processing, literature surveillance, signal detection, aggregate report preparation and regional regulatory reporting.
Signal detection, evaluation and management services including literature review, data analysis and preparation of signal assessment documentation.
Compilation and critical analysis for periodic safety update reports and development safety update reports with regulatory submission support.
Pre-study and ongoing medical review for clinical trials, including review of IBs, protocols, CRFs and DSMB charters and clinical review of safety data.
PV system audits, inspection preparation, gap remediation and support during regulatory inspections.
Management of medical information inquiries with global and multilingual support and KPI-driven service delivery.
Comprehensive outsourced PV operations including ICSR intake and processing, literature surveillance, signal detection, aggregate report preparation and regional regulatory reporting.
Signal detection, evaluation and management services including literature review, data analysis and preparation of signal assessment documentation.
Compilation and critical analysis for periodic safety update reports and development safety update reports with regulatory submission support.
Pre-study and ongoing medical review for clinical trials, including review of IBs, protocols, CRFs and DSMB charters and clinical review of safety data.
PV system audits, inspection preparation, gap remediation and support during regulatory inspections.
Management of medical information inquiries with global and multilingual support and KPI-driven service delivery.
Expertise Areas
- Pharmacovigilance operations and ICSR management
- Safety signal detection and evaluation
- Clinical safety monitoring and medical oversight
- Regulatory safety submissions and risk management planning
Key Technologies
- Electronic Data Capture (EDC) systems
- Pharmacovigilance database platforms
- E2B(R3) electronic safety messaging
- Centralized EU reporting systems (EudraVigilance/CTIS)
News & Updates
Participation in the DIA 2018 Annual Meeting in Boston to showcase pharmacovigilance and clinical safety services.
Announcement of the implementation of the latest Argus safety database system to enhance safety reporting capabilities.
Participation in the DIA Canadian Meeting to discuss pharmacovigilance strategies.
Participation in the World Drug Safety Congress in the Americas to discuss safety strategies.
Participation in the World Drug Safety Congress in Europe to discuss safety strategies.
Participation in the DIA Annual Meeting to discuss pharmacovigilance and safety strategies.
Participation in the DIA 2018 Annual Meeting in Boston to showcase pharmacovigilance and clinical safety services.
Announcement of the implementation of the latest Argus safety database system to enhance safety reporting capabilities.
Participation in the DIA Canadian Meeting to discuss pharmacovigilance strategies.
Participation in the World Drug Safety Congress in the Americas to discuss safety strategies.
Participation in the World Drug Safety Congress in Europe to discuss safety strategies.
Participation in the DIA Annual Meeting to discuss pharmacovigilance and safety strategies.