Operations – ‘Hub & Spoke’ Model
Indian PV (Global Back-end Operations)
UK
Canada
India
LRP
Poland
PV Systems
European Union Qualified Person (EU QP) for Pharmacovigilance and Network of regional LRPVs
- Single contact point that reviews all deliverables
- Deputy QPPV
- 24 x 7 x 365 Coverage
- Network of Local PV responsible persons per specific NCAs requirements
Pharmacovigilance System Master File (PSMF) – Registration Support
- Prepare, advise, oversee and co-ordinate the PV system support from 1st submission of Market authorisation and throughout the product's lifecycle
- Support Module 1.8.1 and 1.8.2 of e-CTD modules
- Revision and updates to PV systems in compliance with regulations
Contractual arrangements with business affiliates
- Draft SDEAs customized as per global regulatory requirements and Review of existing SDEAs
- Exchange of ADRs with business partners after execution
- Managing 150+ SDEAs with Global affiliates of our clients
Medical Enquiry (including access to medic)
- Call receipt 24X7
- Management of standard and off label customer enquiries
- Management of complete cycle from receipt of enquiries to database and response
Operational Services
Eudravigilance registrations and electronic submissions of ICSRs
- Through Gateway (both EMA and FDA) or Web-trader
- Hybrid system capable of both electronic and paper-based submission in multiple regulatory report formats like CIOMS I, Med Watch - 3500A
Periodic Reporting
- PSURs, PADERs, ASRs, DSURs, PBRER and ACOS as per the regulations
- Report generation complying to regulatory formats
Literature Monitoring
- Weekly literature monitoring of Pubmed for identification of ICSRs, Publication studies facilitated by a validated, fully automated software module (LAM)
- Full text articles procurement
- Global literature surveillance for 500 active moieties
PvEDGE
- Web-based, customizable and end user-friendly safety database.
- 21 CFR 11 compliant and based on ICH E2B specification
- Fully integrated MedDRA and WHO-DD browsers
- "E2B R2 and R3 compliant" database
- Additional features like PvD’s Code (Partial automation), Literature automation module and PrITR for medical information
- Compliant database for Device Vigilance and Vaccine Vigilance
Signal detection, evaluation and management
- Use of both quantitative measures and qualitative analyses to detect, as soon as possible, any indication of a potential problem with a drug, either a new or an old drug.
- Experience in almost all therapeutic areas including oncology anti-depressants, biologicals, anti-psychotics…
- Evaluation of EVDAS (Eudravigilance Data Analysis System) Data during signal detection
xEVMPD compliance solution and Services
- As key support services, we take care from data collation, data entry, data checking services to EV submissions of XEVPRMs on behalf of our client
- Experience in almost all therapeutic areas includingoncology anti-depressants, biologicals, anti-psychotics…
Creation and Maintenance of Risk Management Plans (REMS or RMPs)
- Risk management planning during peri or post-authorisation phase of the product lifecycle
- Identification of risk minimisation measures and also evaluation milestones ensuring benefits outweigh the risks
Support Services
PV consulting & Training
- Training PV staff on Global pharmacovigilance legislations and regulations.
- Recommendations for pharmacovigilance department designing, development and improvement.
Quality Management System (QMS)
- Setting up of QMS systems and processes in line with ICH guidance and compliance with local regulations
Global Compliance monitoring and audits and support for Inspections
- Review of the company’s compliance data on a monthly basis
- Support for management of inspections by global regulatory authorities
- Support for CAPA execution for the closure of inspection findings