Post Approval Lifecycle Maintenance
For Pharmaceuticals and Devices Products

Post Approval Maintenance, Support during Merger and Acquisition, Artixio supports pharma and devices companies with managing compliance for marketed products globally.

Services We Offer

Artixio For Your Product Lifecycle Maintenance Solutions

With a solid team of experienced Regulatory and Pharmavcovigilance professionals in global markets, pharmaceutical and device companies trust Artixio with compliance and growth of their products portfolio. Right from Regulatory and Product Lifecycle strategy, continuous intelligence and monitoring to managing health authority relations and negotiations, Artixio has proven experience in delivery excellence leveraging its global project management and best practices.

← End to End Global Product/Market Ownership
for Post Approval Lifecycle Maintenance →

Regulatory Strategy

Dossier Preparation & Submission

Advertising and Labeling

Cross Functional Communication

Post Approval Maintenance & Reporting

PV

Critical Issues Management

RA Representation during Audits

Health Authority Representation & Negotiation

Your Global Partner for Post Approval Lifecycle Maintenance

Global Team of Regulatory Professionals with 5-35+ years of Experience
Proven Experience in Managing Health Authority Expectations and Negotiations
Bilingual Proficiency – English and Regional Language
Diverse Experience – Pharmaceutical, Biologics, NCEs, Medical Devices and OTC
Secure IT Environment for Global Operations – Enabled Through Remote Access
Flexibility to Adapt to Your Changing Business Needs
End to End Product Lifecycle Management Experience
Established Processes to Manage Complex Regulatory Functions
Long Term Relationship with both Clients and Employees
MA Holder / Legal Representation in Several Countries

On-Demand Services

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