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