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Regulatory Support

We manage the Regulatory supply risk so you don’t have to.

That attitude drives the in-house Regulatory team headed by Stephanie Boffa. With decades of supplier- and FDA-facing experience along the entire product development experience—patent assessment, supplier audits, meeting with inspectors at your site—Interchem Regulatory staff can resolve issues surrounding regulatory submissions, quality assurance, cGMP practice and other supply-chain issues.

Regulatory strategy evolves with technology

Interchem Regulatory pre-reviews all DMFs to screen for any supply-based hurdles to your product’s approval. We’re also converting 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 personnel combine 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.

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