Parenteral pharmaceutical packaging is the core of GTA’s work.  Its 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.  Our advisors have extensive experience with the customary materials of glass, rubber and metals, but also with the advanced plastics and laminate materials being promoted today.

GTA’s consulting services include long list activities.  In addition to providing advice and guidance in these areas our advisors can work as liaisons, coordinators or even project managers, linking your staff with our skilled affiliates to assure all your needs are met.

Our advisors 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 advisors are professionals serving on and leading various technical committees, and interest groups of organizations such as PDA, ISPE, ISO and ASTM.  They are teachers, sharing their knowledge at seminars and training sessions around the world.

List of Services:

  • Analytical Methods
  • Autoinjector/Pen and Syringe Compatibility and Specifications
  • Biocompatibility
  • Cold Chain Management and Shipping Studies
  • Combination Products Jurisdictional Issues
  • Compatibility and Stability Studies
  • Container Closure Integrity
  • Container Closure Materials/Component Selection
  • Container Closure System Performance & Functionality
  • Device Quality System, Design Controls
  • DMF Filings
  • Equipment Qualification and Machinability Trials
  • GMP Compliance, Auditing, Inspection Readiness
  • Leachables/Extractables Management
  • Package Design, Development and Evaluation
  • Package Equivalency Studies
  • Packaging Change Control Guidance
  • Packaging Documentation
  • Packaging Regulatory Compliance Guidance
  • Process Validation
  • Quality System Design, Gap Analysis
  • Training and Seminars in Packaging Technology
  • User Studies