EMMA International

Miami, FL · United States

Quality & Compliancesmall

Specialization: FDA quality, validation and compliance consulting

Key Differentiator

Single-source consultancy covering CQV, quality systems, remediation and FDA submissions for drug and device makers.

Core Services

Commissioning, qualification and validation; Computer system validation; Quality system development; Remediation; Regulatory strategy and FDA submissions; Engineering and GMP compliance support

Capabilities

IQ/OQ/PQ equipment and system qualificationProcess and cleaning validationComputer system validationQuality system build and remediationRoutine FDA submissions

Market Intelligence

Headquartered in Miami, Florida. The firm states it is certified as a Women-Owned Business Enterprise by WBENC and as a Disability-Owned Business Enterprise.

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