QUALITY SYSTEMS

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QUALITY SYSTEMS

Establish, deploy or evaluate the Quality Management System (QMS) in place at your facility or your supplier(s). A continuous improvement end-to-end strategy must be part of your business plan. Maintain a high level of  quality with your marketed products.

SUPPLIER SEGMENTATION

A new supplier evaluation process will assist with the assessment of the current processes and procedures in place. A clear understanding of the maturity of the program at the supplier will be delivered. 

DOCUMENTATION & DATA INTEGRITY

The United States Food & Drug Administration is emphasizing data integrity as an integral measure when facility inspections are performed. A proactive assessment ahead of any inspection will benefit every company.

AGILE LAUNCH READINESS REVIEW

Bottlenecks and delays may be hindering your Speed-to-Market (S-2-M) process. Inserting agile concepts into the new product development process will allow for greater flexibility and success with new product introductions (NFI).

ISSUES MANAGEMENT

Monitoring and tracking the issues that may impact your business are one of the critical to quality services we provide. Know the issue so you can address the issue.

AUDIT PRACTICE [COSMETICS & OTC DRUGS]

Regular evaluation of quality systems via an independent third party (consulting) assessment is the most effective way to understand the state of the internal facility or external manufacturer. We specialize in the following audit programs:

Cosmetic Good Manufacturing Practices Certification ISO 22716.

21 CFR Parts 210 & 211 Good Manufacturing Practices for Finished Pharmaceuticals/OTC Drugs.

Technical Audits for Private Equity Investors.