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  • Client Development Stage
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      • Strategic Guidance on Global Trade Compliance
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      • QMS Gap Assessment
      • QMS Implementation
      • Wholesale Distribution Authorisation License Acquisition
      • Swiss Pharmaceutical Establishment License Acquisition
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      • Qualified Person (QP) Services for IMP
      • Audit and Inspection Service
      • Quality and Technical Agreements
    • Supply Chain
      • Inventory and Forecasting (including S&OP)
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      • Artwork and Packaging Optimisation
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      • Transport Management
      • Transport Validation
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Client Development Stage

Preclinical Clinical Launch Planning Commercial

Solutions & Services

Executive Support

  • Strategic Review
  • Entity Structuring & Org Design
  • Launch Readiness Review
  • Global Trade Compliance
  • Managed Access Program

Cross Functional

  • Transport Management
  • Transport Validation
  • Vendor Processes
  • Vendor Selection & Onboarding
  • Vendor Management

Quality Assurance

  • QMS Gap Assessment
  • QMS Implementation
  • WDA License Acquisition
  • Swiss Pharma License Acquisition
  • MAH Point of Contact
  • Responsible Person Services
  • QP Services (Commercial)
  • QP Services (IMP)
  • Audit & Inspection Service
  • Quality & Technical Agreements

Supply Chain

  • Inventory & Forecasting (S&OP)
  • Clinical Supply Chain
  • Commercial Supply Chain
  • Artwork & Packaging Optimisation
  • Serialisation

Customs & Import

  • Valuation Determination
  • EORI Registration Support
  • Import VAT Registration & Management

Test Page

Case Studies

Pioneering Operational Clarity to Power Growth in Orphan Drugs

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Events

Navigating Brexit’s Impact on EU Pharma: Insights from Our Recent Event in Boston

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Articles

Evelyn Kelly, CEO and Founder of Orphan Drug Consulting, Nominated as Finalist for Prestigious Founder of the Year Award 

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Events

Melbourne 2023

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Events

CPHI Barcelona 2023 

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Articles

Emerging Biotech achieves successful European launch with support of Orphan Drug Consulting’s comprehensive approach to navigating diverse market landscape and EU regulations

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European Office

Orphan Drug Consulting, Block 4, Harcourt Centre, Harcourt Road, Dublin 2, D02 HW77, Ireland

North American Office
Orphan Drug Consulting, 1 Broadway, Cambridge, MA 02142, USA
UK Office

Orphan Drug Consulting, 1 Kingdom Street, Paddington Central, London, W2 6BD, United Kingdom

Asia Pacific Office

West Podium, Mezzanine 2, 525 Collins Street, Melbourne, Victoria, 3000, Australia

Services

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