Quality Assurance and Control

Consulting Services

Quality Assurance and Control

Consulting Services

Kinexum provides quality assurance and control consulting services to ensure that you and your vendors conform to Good Laboratory Practice (GLP), Good Clinical Practice (GCP), and Good Manufacturing Practice (GMP).

We can help you create new systems or audit the systems already in place, ensuring that your product is ready for regulatory review.

What is quality assurance?

Quality assurance (QA) focuses on the proactive creation and implementation of systems to ensure the manufacture of a consistent product, supported by precise and accurate data.

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What is quality control?

Quality control (QC) includes retroactively examining both your product (e.g. drug, device, supplement) and your data (e.g. clinical, nonclinical).

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Our services include:

Review of documentation and gap analysis
Creation, review, and implementation of standard operating procedures (SOPs)

GLP training and review in research-stage organizations and transition to regulatory submission-grade documentation

In-person and virtual clinical site and manufacturing QA audits

Regulatory inspection preparation

Third party service provider (vendor) assessment and selection

Project management, trial monitoring, and document and data management (e.g. CRF creation, review of data management plans, edit checks)