Regulatory Strategy Evolves With Technology
Interchem Regulatory pre-reviews all DMFs to screen for any supply-based hurdles to your product’s approval. We convert DMFs to digital form to speed the submission process to meet aggressive GDUFA timelines.
Centralized databases of Regulatory information on API, antibiotic, and custom-manufactured reagents means that most anyone you contact at Interchem can direct you to the product-related information that you need.
InterproQRA: Guidance Beyond Supply
Interchem Regulatory personnel address all regulatory issues that involve a product that we supply.
InterproQRA is Interchem’s sister company that provides comprehensive Quality and Compliance guidance for NDA and ANDA submissions and approval of drugs, biologics, or medical devices. InterProQRA’s personnel combines decades of frontline FDA compliance leadership and extensive pharma experience to deliver true insight—wisdom gained from working on the government and industry sides of the regulatory table.
Learn more at the InterproQRA website.