Combination products are therapeutic and diagnostic products that combine drugs, devices, and / or biological products

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Combination products are therapeutic and diagnostic products that combine drugs, devices, and / or biological products. Because combination products involve components that would normally be regulated under different types of regulatory authorities they raise challenging regulatory, policy, and review management challenges. Med75 Leak tester

Differences in regulatory requirements for component testing impacts the processes for all aspects of product development and management, including preclinical testing, clinical investigation, marketing needs, manufacturing and quality control and any post-approval modifications.

Contact IDC for design insights on how our medical device testing technologies such as the M1075 contribute to the challenges in manufacturing and quality control in these key medical product areas.

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Drug and device combination product (DDCP)

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Mechanical and chemical testing are needed to bring complex drug-delivery products and other combination products to market. A growing number of combination products, along with the overall growth of the pharmaceutical and biologics industry, is driving demand for a more-complex arsenal of tests

Drug and device combination product (DDCP) is merging chemical and mechanical disciplines- it is required by FDA/EMA to have both drug stability as well as the device functionality tests on the same stability program.

M1075 Leak Test Instrumentation

The demands increase for the combined mechanical and chemical testing services to demonstrate that both drug and device are stable and functional through the shelf life of the combination product. IDC with its M1075 medical device testers is providing leading edge technology in such key areas ensuring quality of end products.

These tests play an important role in determining the safety and effectiveness of combination products and are used to show that contaminants from the manufacture, fill, or seal process have not compromised the drug product.

Contact IDC for application details.

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