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Pharmacovigilance Services & Patient Safety Solutions
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
- Receive AE/PQC/MI via calls/fax/ email/ website /affiliates
- Complaint documentation
- Mailbox management
- Social media screening
AE Case Processing
- AE Intake & Triage
- Case processing in safety database
- Narrative writing
- Medical Review
- Submission
- Follow up
Product Complaint Management
- Handling of product complaints for Pharma/Medical devices
- Defective sample handling
- Coordination for Investigation Report
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
- Health Hazard Assessment
- PSMF Authoring and Update
- New RMP authoring
- RMP Updates
- RMP maintenance
- Risk Evaluation & mitigation strategy
Audit & Inspection Support
- Audit readiness
- Compliance monitoring
- Periodic checks
- Inspection support
- CAPA management
Safety Data Exchange Agreement
- Draft & Review the SDEA
- Data collection & coordination
- SDEA schedule & maintenance
- SDEA renewal
- SDEA archival
QPPV Office
- EU-QPPV support
- EA EU QPPV support
- LPPV/LPVRP support
- SPSMF management
- Eudravigilance support
Affiliate Support
- Local point of contact for country support
- Local case intake & processing
- Local HA communications & coordination
- Handling of local PV activities
Technology Services
- Safety database hosting & implementation
- Validation support
- Automation tool development
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.
Pharmacovigilance for Global Markets
Driven by key regional regulatory and market insights, Artixio enables seamless product compliance monitoring and patient safety through proactive pharmacovigilance strategies.
Efficient Centralized Solutions
Hybrid model for centralized, high quality safety services that drive efficiency and cost effectiveness combined with regional pharmacovigilance expertise to manage large scale global operations.
Regulatory Excellence in Every Step
At Artixio, we bring insights from successful regulatory approvals and hands-on experience across various markets and product categories. By combining regulatory best practices with practical know-how, we deliver reliable and efficient solutions that support your compliance goals with confidence.
Why Artixio For Pharmacovigilance Services?
- 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?
3. What challenges do companies face in global pharmacovigilance and how do you address them?
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
Still Have Questions ?
Specialized Pharmacovigilance
Services Across Multiple Industries
Pharmaceuticals
MedTech
Cosmetics
Nutrition
Biologics
Veterinary
Expert Regulatory Services To Streamline Compliance
Regulatory Intelligence & Strategy
Medical & Technical Writing
Publishing & Submission
Regulatory Affairs Across Multiple Countries
India
Singapore
Mexico
Brazil
Vietnam
Malaysia
Argentina
Colombia
Taiwan
China
European
Thailand
Indonesia
Philippines
USA
Japan
Qatar
South Korea
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