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What We Do
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ANADA development and regulatory filing
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FDA, DEA, and State Regulatory Compliance
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Product development in sustained release and controlled release formulations
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Controlled substance handling (CII–CV)
Regulatory Vision
Regulatory Navigation We evaluate your product portfolio and develop a compliant US regulatory pathway. Whether your product requires an ANADA filing, our regulatory affairs team manages FDA submissions, correspondence, and responses from start to approval.
US Commercialization
We bring products to market across all trade channels — distribution, veterinary GPO, mail order, and farm — with a comprehensive launch strategy that begins well before your product hits the shelf and continues for the full lifecycle of the product.
Third-Party Logistics
Through Reassurance Logistics, we provide pharmaceutical-grade 3PL services to manufacturers and marketers who need a trusted US distribution partner. Our service level is consistently regarded as among the best in the industry.
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