Regulatory Support

Support that Delivers Regulatory Approvals

Working closely with partners at every stage, Next Breath adopt a rigorous, regulatory stance to ensure the requisite product stability and quality standards are met. This diligence and expertise critically improves ANDA Submissions bioavailability and bioequivalence documentation. Next Breath is regulatory and cGMP oriented with a proven track-record of working with regulatory agencies to ensure a high product approval rate. After all, efficient regulatory approval is our shared end goal.

Global Regulatory Experience

United States

Americas

Canada (Health Canada)

India

EU (European Medicines Agency) & Australia

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