Global Pharmacovigilance Services

Global Clinical and Post Market Safety and Pharmacovigilance Services for Pharmaceutical and Biotech Industry

Services We Offer

Why Artixio For Your Pharmacovigilance Solutions?

In ever evolving, dynamic global regulatory environment, patient safety through effective Pharamacovigilance (PV) is critical for manufacturers. Artixio offers a range of Pharmacovigilance (PV) services across pharmaceutical and biotech product clinical development and post-marketing helping our clients achieve excellence in patient safety. Our cross functional team covers comprehensive range of services across PV value chain.

Post Market Surveillance → Safety Surveillance → Allied Safety Activities

Literature Management

Literature screening of global & local literature
Design search strategy
Validity assessment of literatures
Review of ICSR & Non-ICSR
Market Access Strategy
Full text article procurement
Translation

Intake Services

AE Case Processing

Product Complaint Management

Medical Writing

PADER/PSUR/PBRER/DSUR
Authoring
Review
Publishing
Submission
Aggregate report scheduling
Adhoc reports

Signal Management

Signal Detection
Quantitative Analysis
Qualitative Analysis
Signal Validation
Potential Signal
Valid Signal
Refuted Signal
Signal Prioritization

Risk Management

Audit & Inspection Support

Safety Data Exchange Agreement

QPPV Office

Affiliate Support

Technology Services

Elevate Global Patient Safety through Artixio’s Hybrid (Centralized and Regional) Pharmacovigilance Services

Our 100+ Pharmacovigilance experts based centrally and regional countries across 70+ key global markets have helped thousands of biotech and pharmaceutical companies successfully maintain safety using proven best practices. Coupled with Artixio’s intelligence-based services platform, Dvarka, innovators and manufacturers from around the world have benefited by managing the pharmacovigilance strategy seamlessly across the clinical development and post market surveillance.

What Sets Us Apart ?

Successful Case Studies Pharmacovigilance and Safety Monitoring for 500+ products
Diverse Products Experience across Complex Products Categories and Therapeutic Areas
Strong Regional Expertise in 70+ markets with 15-35 years of experience
Proven Experience in End to End Product Value Chain from Clinical Development to Post Market
Health Authority Experience in Navigating through Complex, often Ambiguous Regulations
Intelligence driven, global pharmacoviglance services supported by regulatory intelligence platform, Dvarka
ISO 9001:2015 quality standards governed services
Customer focused, flexible services and solutions
Flexible Business Model including project based, managed services and FTE staffing model
Hybrid-Local-Centralized Support across Safety functions

FAQs

1. What are key components of global pharmacovigilance?

Global phramacovigilance encompass a variety of activities, including regulatory intelligence and strategy for pharmacovigilance implementation, maintenance and monitoring. Pharmacoviglance includes combination of centralized and regional PV activities such as CIOMS Reporting on ADRs, Case Processing, Literature Review, PSUR Submission, RMP Submission, Local QPPV or safety responsible person, Local PSMF, Distribution of Direct Healthcare Professional letters, Review Labeling and Artwork among others.

2. How do you support Pharmacovigilance across multiple countries?

Artixio uses hub and spoke model using a centralized pharmacovigilance team including Project Managers, PV Managers, PV specialists, Medical Reviewers to support activities across literature review, case processing, medical review and report authoring and submissions. The central team works closely with regional PV specialists and Qualified Responsible Persons for PV to ensure product safety and compliance in international markets. Regional submissions are performed by Artixio’s regional team members including continuous LQPPV activities such as Acting as a local contact point for Local Health Authority and Qualified Person for Pharmacovigilance & Deputy of QPPV, •Handling Local Health Authority Requests, sending monthly reports, where required by local legislation, ongoing documentation of LQPPV activities and ADR Monitoring.

3. What challenges do companies face in global pharmacovigilance and how do you address them?

Few challenges that companies face while managing global pharmacovigilance include, but not limited to, lack of knowledge of local regulations related to pharmacovigilance, post market surveillance and products safety, lack of experience, regional language and cultural nuances, lack of trusted expert with global perspective, irregular processes, inconsistency in documents, requirements for part-time pharmacoviglance experts for managing small portfolio of products, requirement for a Local Qualified Person responsible for PV (LQPPV) intellectual property security, quality of documentation, transparency, maintaining compliance with changing regulations, products portfolio revenue versus cost of compliance/ ROI and others.

Artixio addresses these challenges by providing flexible, budget friendly and timely pharmacovigilance services including LQPPV using global standards for seamless projects delivery, secure information exchange, high quality services, regional expertise and network and systems driven processes.

4. How do you stay updated with global regulatory changes related to pharmacovigilance?

Artixio has internal regulatory intelligence platform, Dvarka, that tracks global regulatory changes related to pharmacovigilance. The platform hosts,

Current regulations, directives, regulatory insights
Track changes in regulations, new guidelines, notifications from health authorities worldwide related to pharmacovigilance, post market surveillance and products safety
Insights by our Regional Regulatory Experts from their experience, attendance to Conference, Seminars, Trade Shows, HA Organized Trainings and Events
Artixio’s expert opinions and Case Studies