Combination Products

SMC’s full service capabilities include the manufacturing of combination products.

SMC’s full service capabilities include the manufacturing of combination products.  This includes handling of drugs and biologics in the primary packaging for integration into the final delivery device assembly.

  • FDA 21 CFR Part 4 compliance
  • Pre-filled syringes, glass or plastics cartridges, aluminum canisters, foil blisters, capsules, mini-tablets
  • Specialized controlled environments for cold chain, humidity, and UV sensitivity
  • Additional security and infrastructure for controlled substances
  • Reconciliation of drug, labels, and IFUs
  • Implementation of required registrations and permits
  • FDA pre-approval inspection readiness
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