Pharmacovigilance

We offer Pharmacovigilance services with up-to-date and in-depth knowledge and expertise due to dynamic Pharmacovigilance and regulatory changes globally.

Our Services

Entrust your Pharmacovigilance needs and expectations are in the experienced hands of our Team. Whether an urgent solution for an unanticipated challenge or services for end to end Pharmacovigilance process – our knowledgeable expert team will be right there for you.

Safety Report Management

With optimized tool for collection, processing and review of safety reports, entire case management is managed by experienced Pharmacovigilance team until reporting to relevant stakeholders including competent authorities.

Safety Regulatory Reporting and Regulatory Intelligence

Expedited and periodic reporting to Investigators, EC/ IRB, business partners as per requirements. Health Authority submission through E2B R2/ R3, Eudravigilance, portal etc. Regulatory Intelligence management. Compliance tracking and CAPA management.

Risk Management

Preparation, review and update of RMP document, safety updates according to regional regulatory requirements. Pharmacovigilance expert support as representative to participate as representative of single shared REMS program.

Pharmacoepidemiology

Design, conduct and manage post authorization safety studies and other risk minimization activities.

Signal Management

Comprehensive monitoring of signals by both qualitative and quantitative approach from different sources of safety data and preparation, review and communication of signals.

Literature Surveillance

Monitoring of safety information through technology enabled literature search and review with dedicated literature review physicians.

SDEA Management

Preparation, maintenance of Safety Data Exchange Agreement (SDEA) with external stakeholders including Licence partners and accomplishing the Pharmacovigilance activities as defined in agreement ensuring quality and compliance.

Reconciliation and Compliance Tracking

ADR reconciliations and compliance tracking for marketed products with all stake holders to ensure compliance and documentation. SAE reconciliation in Clinical trial for data consistency and accuracy.

Pharmacovigilance System Management

Oversight and manage entire Pharmacovigilance system from due-diligence, Pharmacovigilance set-up till preparation and maintenance of Pharmacovigilance system master file.

Qualified Pharmacovigilance personnel

Consulting services as per local/ regional regulatory requirements for the QPPV, Local safety officer/ QP/ National responsible personnel for Pharmacovigilance.

Training and Development

Set-up, prepare and maintain quality management system for Pharmacovigilance activities, training of Pharmacovigilance staff on routine and additional Pharmacovigilance activities and during regulatory updates.

PSMF Preperation and Maintenance

Preparation, review and update of Pharmacovigilance System Master File (PSMF) for EU marketed products according to regulatory requirements.

Our advantage

Experienced team

Experience in handling patient safety during clinical trial and post marketing.

Domain knowledge

Regulatory requirements across continental.

Established process

Effective Pharmacovigilance systems in compliance with regulatory requirements.

TECHNOLOGY

Safety database and compliance tools.