TOSALL India Private Limited provides pharmacovigilance services in Bangalore to small, mid and large sized pharmaceutical and biotechnology companies.
Our solutions includes end to end ICSR management (including case intake, data entry, MedDRA coding, triaging, Quality review, medical review, regulatory submission, etc.), generation of expedited and periodic reports, Qualified Person for Pharmacovigilance (QPPV) services, medical literature review, analysis and trending of cases (signal detection), and medical information call center services inclusive of medical inquiries, adverse event and serious adverse event case intake and handling product quality complaints.
Our team consists of highly qualified medically professionals and skilled experts who are committed to help life sciences companies meeting the regulatory expectations timelines by maintaining and safety and risk management of their products.
Medical Information Call Center
We have dedicated Medical Information call centres staffed with extensive teams of medical professionals. Our centres are offering 24*7 services along with multi language support.
MICC services include, but are not limited to:
- Managing Medical Information inquiry, product quality complaints and adverse events
- Preparing and maintaining FAQs for client products
- Support in preparation of process documents: SOPs, Work Instructions and forms and templates
- Conducting comprehensive training sessions for medical information staff for accent neutralization and Call Center etiquettes.
- Comprehensive enquiry receipt, response/processing and documentation and share with clients in stringent timelines
- Ensuring implementation of appropriate quality control and assurance procedures to maintain compliance
ICSR Management
We segment the process of adverse reporting for pre- and post-marketing cases into five steps: Case Intake, Case Processing, Quality review, Medical Assessment and Submission. Routine Quality Assurance (QA) procedures ensure that our services adhere to governing SOPs, regulatory guidelines, and overall corporate policies of pharmacovigilance services in Bangalore.
Medical Literature Search and Review
We have fully customizable literature monitoring and tracking tool that ensures organizations have timely access to reliable and consolidated information on relevant safety related literature. The tool monitors all safety related literature and creates reports of ICSR’s. Our tool has been used to monitor literature for following:
- Clinical Evaluation
- Pre-market Approval
- Adverse Events Reporting
Aggregate Reporting Services
We have a unique modular approach to aggregate reporting activities that emphasizes an organized effort in the writing of PBRERs, PADARs, DSURs and other aggregate reports. Experienced and trained personnel write all sections of the reports including medical assessments, benefit-risk assessment, executive summary, and the business and sales section.
A dedicated medical team provides assessment and guidance, to ensure that medical consistency is maintained across all reporting forms for regulatory submission. Our team’s objective is to optimize the periodic report preparation process to enable the surveillance and signal detection that allows for the delivery of greater patient safety.
Our Risk Management program begins with the assessment and identification of risks and potential risks associated with a product. Based on these risks, we work with clients to develop risk minimization plans and the implementation of a risk management plan.
Other services include:
- Risk Assessments
- Medication Guide
- Patient Package Insert
- Communication Plan
- Mechanisms to Restrict use of the Product
Qualified Person for Pharmacovigilance (QPPV)
We provide QPPV, deputy QPPV as well as local PV responsible services for clients entering the European market to ensure appropriate management of the Marketing Authorization Holder’s (MAH’s) pharmacovigilance services in Bangalore with systems in the EU. This includes managing efficient communication with regulatory authorities and providing oversight of the MAH’s or client’s safety systems, processes and procedure
Signal and Surveillance Management Services
Our highly medically professional teams supports pharmaceutical companies in Bangalore with adopting signal management processes, consisting of detection, validation, confirmation, analysis and prioritisation, assessment and recommendation for action in accordance with European legal requirements.
- Visualization – Evaluate medical significance of signals using sophisticated visualization techniques that simplify the process of signal screening of aggregate data
- Data Sources – The use of external data sources (company data and external data sources such as FDA AERS, WHO vigibase) allows for estimates of differences from known background rates. These data sources can be used for the review of data mining, as well as the statistical analysis of signal scores for client products as well as competitor products.
