Regulatory counsel for pharmaceutical drug product quality Contact us Since 2011
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Pharmaceutical Quality & Regulatory Counsel

Regulatory credibility, built to withstand scrutiny.

DP Quality Consulting guides drug manufacturers through FDA observations, remediation, and the audits that follow — with the discipline of a firm that has stood in the room during an inspection.

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Sterile Injectables Oral Dosage OTC & Generic Compounded Rx
120+FDA responses drafted and filed
40+Mock pre-approval audits conducted
3Dosage-form categories served: sterile, oral, topical

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Request a rapid assessment.

Two questions is enough for a senior consultant to give you an initial read — no obligation, and a response within one business day.

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Every engagement begins under NDA — your findings stay confidential.

Who we serve

Drug product manufacturers under active regulatory scrutiny.

Sterile Injectables
Ophthalmic Products
Oral Solid Dose
Topical & Transdermal
Generic & OTC Manufacturers
Compounded Pharmacies (503A/503B)
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“The firms that fare best with the FDA aren't the ones with the fewest findings — they're the ones whose response earns the investigator's confidence.”
DP Quality Consulting