Expertise
FDA-experienced quality, compliance and technical consulting
We work where regulation meets operations: quality systems, cGMP manufacturing, validation, laboratory compliance, investigations and remediation. Every engagement is staffed with consultants who have done the work, not only reviewed it.
01
Quality Systems & Compliance
Quality system design, remediation, investigations and the programs that keep a system in control.
Quality Systems & cGMP
Design, assessment, optimization and remediation of pharmaceutical and regulated quality systems.
View expertise →CAPA, Deviations & Remediation
Root-cause investigations, CAPA systems, deviation management and sustainable corrective actions.
View expertise →Medical Device Quality & QMSR
Quality management systems, QMSR, ISO 13485 alignment and device manufacturing compliance.
View expertise →Supplier Quality & Audits
Supplier qualification, audit programs, contract manufacturer oversight and due diligence quality audits.
View expertise →Regulatory Compliance Support
Registration, submission support, labeling review and Agency correspondence alongside quality and compliance work.
View expertise →Regulatory & Submissions
Manufacturing, CMC and quality content for 510(k), De Novo, PMA, IDE, IND, NDA, ANDA and BLA submissions.
View expertise →Training
Practical GMP, quality system, investigation and data integrity training built around your operation.
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02
Development, Manufacturing & Validation
Support from formulation and scale-up through validated, controlled commercial production.
Pharmaceutical Development & Manufacturing
Quality and compliance support throughout development, scale-up, technology transfer and commercial manufacturing.
View expertise →Validation & Qualification
Process validation, cleaning validation, equipment qualification, IQ/OQ/PQ and lifecycle validation support.
View expertise →Sterile & Aseptic Operations
Quality and compliance support for sterile manufacturing, aseptic processing and contamination-control systems.
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03
Laboratory, Data & Clinical Quality
The data behind release, stability and submission decisions, and the systems that protect it.
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Tell us what you're working on.
Describe the product, the process or the problem. We will tell you honestly whether we are the right people to help, and who should be on the team if we are.