We frequently see clients needing to outsource many of their activities and adopt a “virtual pharma” model. Manufacturing, distribution, artwork, packaging, complaint management, offices/facilities, IT support, Responsible Person (RP), Qualified Person (QP), pharmacovigilance, regulatory support are key services which we typically see outsourced.
Vendor Management
Leveraging best-in-class vendor selection through an extensive supplier network to address your chosen strategy with ongoing vendor management to ensure a seamless ongoing service.
While your vendors perform work on your behalf, it is crucial to understand that the quality of their work directly impacts not just your business but your reputation with the regulatory authorities as your organization is the product license owner. Understanding the particular skill set required to manage this environment is crucial to your organization’s success.
Orphan Drug Consulting brings years of expertise in managing relationships with your vendors. We have worked with multiple vendors globally across a range of different products and projects and can support you and your team in the most effective selection and implementation vendor processes, ensuring you get the highest quality of service at an optimum cost.
Key Strategy Impacts
- Partnership Selection Support and Advice on Supply/Compliance Activities
- 3PL/CMO Request for Proposal (RFP) Process
- Supplier Qualification Activities Including Due Diligence Visits & Agreement Negotiation
- 3PL Implementation and Launch Management
- CMO Technical Transfer Planning
- Packaging & Shipping Validation
- Artwork Implementation
- Packaging Optimization
- Resolution of Manufacturing issues
- Ongoing Vendor Management and Support
- Dispute Resolution
- Supplier Audits
- Supplier Deviations/CAPA’s/Change Controls
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