QMS MANAGEMENT
Development
and Implementation
Many of our clients are small organizations just entering the regulatory phases of drug and/or device development. As these organizations move into Phases I and II, they are often in need of assistance with the development and implementation of quality systems that will not only be phase-appropriate but also grow with the company through later development phases and commercialization. Quality Confidential has expert consultants available to advise companies on what quality elements are needed for their QMS management at each phase of drug development. Our consultants have written Quality Manuals and quality systems procedures for both clinical and commercial organizations.
Regulatory and
Notified Body Audit Responses
Regulatory and Notified Body audits may result in “compliance findings” or “observations.” These notifications of non-conformance (483s, Warning Letters, Findings Forms, etc.) require special handling from a multi-disciplinary team that includes personnel at the top levels of company oversight and legal representatives. Failure to handle responses correctly and within the required time period can result in rejection of establishment applications, ineligibility for ISO certifications, delayed regulatory submissions, fines, recalls and increasing levels of regulatory action. Quality Confidential consultants have been working within our regulated industry for many decades and are experts in working on and leading audit response teams. We can quickly deploy a consultant - or team of consultants - to assist our clients in handling audit responses.
Remediation
Companies that have received a Warning Letter or are operating under a Consent Decree are required to identify and perform remediation of the system(s) that led to the compliance failures. Quality Confidential has worked closely with multiple companies to remediate quality systems and procedures. Our highly-qualified consultants can assist with all aspects of the remediation; including, but not limited to; the initial response, monthly updates to regulatory bodies, root cause analysis, gap analysis, identification of corrective and preventive actions, update of quality system manuals and procedures, and training of personnel.