Quality & Compliance

The assurance of quality and compliance with regulations is best managed with the design of customized quality systems. We can assess the adequacy and compliance of existing quality systems or implement stage-appropriate quality management systems (QMSs) to ensure compliance and well-controlled development. This includes the development of initial QMSs from-the-ground-up, e.g., creation of quality manuals, policies, and standard operating procedures and associated forms, and their implementation.

SciLucent can act as the Quality Assurance function in all stages of development. This includes the management of the QMS including systems such as documentation control, training, change control, corrective and preventative actions (CAPA), quality investigations, vendor qualification, etc. We author and negotiate vendor quality agreements, oversee vendor compliance, review and approve GxP-regulated documentation, and lead quality investigations into deviations, out-of-specification results, and issues of noncompliance.

Effective sponsor oversight of manufacturing and controls, for both development- and commercial-stage products, is critical to any successful company. We ensure compliant QA oversight for manufacturing activities both internally and in relation to contract vendors. We are experienced in all phases of development, knowledgeable in the nuances of manufacturing and controls, and proficient in the review and approval of controlled documentation.

Integrity of clinical trial data and the safety of trial subjects are imperative for any clinical study. A high level of quality associated with the clinical study data is critical to ensure that the study results are interpreted correctly. We manage clinical quality assurance functions at all stages of clinical development. We have experience developing GCP qualification and approval programs for the selection of contract research organizations, clinical trial sites, and central laboratories for the conduct of a clinical trial. We assist in the development of the Trial Master File (TMF) plan and the TMF for completeness of regulatory documentation. We can also provide on-site GCP training.

Proactive, initial, and routine evaluation of vendor GxP compliance minimizes the risks of quality issues and development and supply chain disruptions. Routine auditing can also mitigate the occurrence and severity of impacts that accompany health authority audits such as issued compliance observations (e.g., Form FDA 483), warning letters, market restrictions, consent decrees, etc. We conduct audits for organizations operating under GLP, GMP, GMP and CAP/CLIA compliance requirements or accreditation. These include laboratories, CMOs, nonclinical and clinical CROs, Phase 1 units, bioanalytical specimen storage and testing laboratories, and clinical trial sites, as either part of vendor qualification, routine, or for-cause audits. We assist in preparing for Bioresearch Monitoring (BIMO) or Pre-Approval Inspections (PAIs) with mock-inspection, which can dramatically mitigate delays or prevent nonapproval of marketing applications.