According to the FDA, a Combination Product is defined as: “Therapeutic and diagnostic products composed of any combination of a drug and a device; a biological product and a device; a drug and a biological product; or a drug, device, and a biological product.”

Some estimates suggest that up to 30% of recent FDA submissions are combination products. As a result of this growing trend, the FDA has set up a separate department for the review of such products. The potential benefits of Combination Products include:

In summary the key features of Combination & BioPharm Product Manufacturing at MDM are:

  • The ability to localize treatment
  • Reduction in labor, time and
  • Reduction in risk of contamination and
  • Precise dosage control

At MDM, for the production of Combination and BioPharm products, activities such as Fill/Package are performed in a Class 100 Cleanroom. All manufacturing and warehousing is cGMP compliant. Our featured services include the low-cost and rapid scale-up manufacturing of Phase I Pharmaceuticals and Combination devices.

We specialize in:

  • Aseptic Transfer-Vials and Syringes
  • QC Testing
  • Compound Blending
  • Stability Testing
  • Biocompatibility Testing
  • Endotoxin Testing
  • Packaging and Sealing
  • Packaging Validation
  • Sterilization Validation
  • Fulfillment and Distribution (GMP Compliant Warehouse Controls)

The production of Combination Products involves regulatory requirements from traditionally diverse divisions of the FDA (Device, Drug & Biological). To assist you through this process, MDM also offers its regulatory experience to clients in seeking FDA approval for their products.