Global Reach

Quality Assurance strategy, quality management system (QMS) development and maintenance, as well as obtaining and maintaining appropriate product licenses on behalf of clients (e.g. RP/QP services).

Here at Orphan Drug Consulting, we understand that compliance not only spans the traditional Quality Assurance (QA) role but covers a wide range of activities.

Our team bring the best of industry expertise to these activities with experience obtaining, implementing and maintaining multiple Manufacturing/Importers Authorizations (MIA’s) and Wholesale Distribution Authorizations (WDA’s). The team has acted as both Qualified Person (QP) and Responsible Person (RP) on these licenses and currently fulfill these roles for several clients along with having extensive experience in authoring Quality Management Systems and hosting successful regulatory agency inspections.

We support Marketing Authorization (MA) activities, acting as a point of contact with the European Medicines Agency (EMA) on MA’s and ensuring your entity remains compliant with its MA obligations by implementing a cross-functional responsibility matrix. Other areas that the team support include QA oversight of technical transfers into contract manufacturers, set up of third party logistics (3PL’s) and providing input into launches by ensuring local requirements are understood and implemented as part of the launch plan.

Key Strategy Impacts

  • QMS Development and Management

  • WDA/MIA License Acquisition

  • Nominated QP on Client MIA Ensuring GMP Compliance and Subsequent Batch Release to Market

  • Nominated RP on Client WDA Responsible for Distribution and GDP Compliance

  • Designated Point of Contact on MA’s

  • Training for Local and Global Teams

  • Conducting Audits Globally
  • Regulatory Inspection Preparation, Hosting & Management

  • Vendor Qualification & Oversight

  • Shipping Validation

  • Quality & Technical Agreements

  • Recall and Complaint Management Including Reg

  • Authority Reporting

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