We can support your technology development with advice, technical evaluation, risk assessment, data and document review or hands-on development activity, as necessary.

We are very familiar with;

  • Developing User Needs, Selection Criteria and/or Design Inputs
  • Supporting technology landscaping, technical Due Diligence and evaluation, feasibility assessment and technology selection
  • Risk Management
  • ISO/CFR Design Control, Design History File, Conformity Dossier and Essential Requirements
  • Design Verification, Traceability, Test Method development and Test Method Validation
  • Device Master Record
  • Submission and Inspection Readiness
  • Change evaluation
  • Complaints review
  • Impact evaluation of new regulation, legislation or guidance

We have developed deep technical proficiency with many drug delivery technologies including the following…

  • For injection…
    • Vial systems (eg: Transfer Spike, Transfer Syringe)
    • Syringe systems (eg: Pre-Filled Syringes, Needle Safety systems)
    • Injection systems (eg: Auto/Pen Injector, Patch Injector)
    • Reconstitution devices
  • For Inhalation…
    • Dry Powder Inhalers (eg: Capsule, Pre-metered & Reservoir)
    • Pressurised Metered Dose Inhalers (pMDI) and dose counters
  • For Oral…
    • Graduated dosage delivery systems (eg: Cup, Adaptor, Dispenser)
    • Tablet dispensers (Calendarised, User-friendly)
  • For Transdermal…
    • Micro-needle Patches, Patch Applicators
  • For On-boarding…
    • Demonstration & Training Devices

Inh modNSD modPen modThese competencies are directly transferable to other drug delivery approaches.

Why not engage us in your technical activities?

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