Local Affiliate Services
We provide unmatched local expertise in all compliance areas, fully substituting and enhancing traditional biopharma affiliate functions. As the sole point of contact for all local compliance needs, we simplify and streamline support for biopharma companies. This distinctive capability makes us the only provider with such extensive and effective coverage.
Our Services
Local Affiliate Services with An Integrated Cross-Functional Expertise
Local Pharmacovigilance
- Local QPPV / Local Person for PV (LPPV)
- Local Literature Screening
- Local ICSR Management
- Local PV regulatory intellingence
- Implementation of aRMMs (Educational Materials, DHPC)
Local Regulatory Affairs
- Health Authority contact
- Professional advice and regulatory consulting
- New MAA & Product Approval
- Product life-cycle management
- Local Regulatory Intelligence
- Artwork review & management
- Promotional Materials review and approval
Market Access
- Regulatory Intelligence
- Pricing applications
- Consulting on national reimbursement strategy
- Reimbursement applications
- Price negotiations with national authorities
- Support with risk sharing agreements
- Support with early access programs (EAP, CUP, NPP)
QA & Compliance
- Stock management support (shortage/stock out, product recalls, quality issues)
- Management of product quality complaints (PQC)
- Consulting on local GDP requirements
- Management of serialization requirements, liaison with NMVOs
- Review of HCP engagement, HCP/events sponsorship disclosure
- Promotional Materials & Activities Compliance
Our Local Operating Model
Unified Governance Model
We believe that the management of country-level activities on an international scale requires a structured & strategic service delivery approach. Thus, throughout all countries of our presence we operate under the same Unified Governance Model consolidating our individual country operations into a seamless integrated regional system. Under our unified governance model we deliver a consistent service, harmonized outputs, and unified reports, assuring compliance region-wide
Unified Approach
One Team - One Approach
Insuvia’s organic growth ensures a unified team and streamlined communication across all service areas and territories, delivering consistent, high-quality support. Unlike firms fragmented by acquisitions or subcontracting, our vertically and horizontally integrated structure enhances responsiveness and client service, ensuring a seamless experience for every client in each country we operate.
Global Reach
Local Expertise – Global Capabilities
Leverage our extensive geographical coverage combined with deep country-specific expertise to navigate regulatory compliance at the regional and local affiliate level. Our resources span Europe, Eurasia & CIS, MENA, Asia Pacific, and Latin America, providing our clients with the necessary insights and capabilities to succeed globally. Our commitment to scale and adapt alongside our clients ensures robust support as you expand into new territories, offering consistent, high-quality assistance every step of the way.