Affiliate Level Solution | Pharmacovigilance

Flexible, compliant and cost effective

With the global harmonisation of local pharmacovigilance (PV) regulations, the role of affiliates has evolved into a dual role - driving commercial growth and managing pharmacovigilance activities. Regulatory and PV operations have become increasingly burdensome, and the complexity of pharmacovigilance continues to grow.

Our pharmacovigilance experts provide an efficient and regulatory-compliant solution while retaining the expertise of a local presence. A centrally managed, geographically dispersed model leverages our established processes and technology infrastructure. This flexible outsourced solution ensures your head office and affiliates have access to skilled resources when needed, while maintaining essential oversight of local activities.

91�� delivers an affiliate service to 80 countries, with established capabilities in many more.

Our team has a proven track record of successfully delivering projects within the affiliate model across Asia, the Pacific, Europe, North and South America, the Middle East, and Africa, achieving over 99% compliance in ICSR submissions.

Benefits

Time efficiencies

A global, scalable infrastructure enables flexible, dynamic, and rapid roll-out of PV services across all regions
Consolidating from multiple vendors to a single provider significantly reduces the time spent on audits and coordination

Increased quality and compliance

Local PV expertise and consistent, integrated workflows ensure regulatory compliance
Full transparency and oversight of both country-level and global performance metrics support ongoing compliance
Robust quality management systems and continuous improvement processes minimise risks and drive efficiencies

Reduced costs

Streamlined processes support operational excellence, optimising both time and cost efficiency
The need to hire additional resources in countries without direct sponsor representation is eliminated, reducing overhead costs

In-country PV support

Based on the product launch strategy, 91�� can support establishing the Local Person for PV (LPPV) network and subsequently offer the below services.

Global footprint and range of available services

Global infrastructure

Specialised and well-structured procedures, processes, technology and local relationships in place
Over 80 countries across the globe, with active expansion, including emerging markets
Robust technology infrastructure available to support clint needs, as required

Expertise and experience

A dedicated team with a proven track record in successfully delivering projects within both the affiliate and FSP models
Services include support from QA, Legal and Procurement

Full range of services

Clinical Trials
Post Marketing
Medical Devices
In vitro Diagnostics
LPPV requirements

Whitepaper: Affliliate level solution

This whitepaper explores the benefits in adopting an outsourced model for pharmacovigilance that is centrally managed and geographically dispersed, ensuring efficient and compliant delivery whilst retaining the effectiveness of a local presence.

Case study: Affiliate level solution

A mid-size pharmaceutical company with numerous affiliates and local vendors across 80 countries sought a reliable partner for effective Pharmacovigilance (PV) and Medical Information (MI) services.

91��

Flexible, compliant and cost effective

91�� delivers an affiliate service to 80 countries, with established capabilities in many more.