Consulting

Our consulting services include long list activities. In addition to providing advice and guidance in these areas Genesis can work as a liaison, coordinator or even project manager, linking your staff with our skilled affiliates to assure all your needs are met.

How Can We Help?

Parenteral pharmaceutical packaging is the core of our work.  It’s scope includes the traditional, vials with elastomeric stoppers, cartridges and pre-filled syringe systems, and in developing novel and innovative components, and drug delivery systems including combination products.  We have extensive experience with the customary materials of glass, rubber and metals, but also with the advanced plastics and laminate materials being promoted today.

What We Do...

We are very knowledgeable of the regulatory requirements and guidances concerning the packaging of pharmaceuticals and container closure systems and have experience with US and worldwide authorities. Our consultants are professionals serving on and leading various technical committees, and interest groups of organizations such as PDAISPEISO and ASTM.  They are teachers, sharing their knowledge at seminars and training sessions around the world.

Container/Closure System Development
  1. —Dosage Form Considerations
  2. —Market Needs
  3. —Materials of Construction
  4. —Specification Development
  5. —Component Selection and Design
  6. —Form, Fit Function
  7. —Identification of Critical Q Attributes
Product/Process Improvements
  1. Processing/Handling Optimization
  2. —Investigation Support
  3. —Efficiency and Yield Increases
  4. Quality Enhancement
  5. Regulatory Support
Container/Closure System Evaluation and Qualification
  1. —Extractables and Leachables
  2. —Container Closure Integrity
  3. —Functionality
  4. —Machinability
  5. —FMEA
  6. —Risk Assessment
Supplier Management
  1. —Selection and Qualification Support
  2. —Supplier Quality Agreements
  3. —Supplier/Packaging Evaluations
  4. —Change Management
  5. —Improvement Projects
  6. —Site Visits/Audits
Training and Education
  1. —Selection and Utilization of Glass Containers for Parenteral Packaging
  2. —Understanding Glass Quality (PDA TR 43)
  3. —Selection and Utilization of Elastomeric Components for Parenteral Packaging
  4. —Extractables and Leachables
  5. —Suitability of Packaging: Drug-Packaging Compatibility
  6. —Container/Closure Integrity and Testing
  7. —Processing and Handling of Parenteral Packaging Components
  8. —Fundamentals of Lyophilization: Principles and Practices

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