Services
Our Core Services
Documentation
Our services encompass creating and maintaining SOPs, policies, quality manuals, protocols, reports, and MBRs to ensure compliance with GXP regulations and promote consistency and adherence to industry standards.
Read MoreOrganizational Structures
We assist in defining, establishing, and evaluating organizational structures, roles, and responsibilities, including sponsors, QU (QA and QC), executive management, and CMC teams, aligning with GxP regulations and guidelines.
Read MoreQuality Management
We provide comprehensive support in establishing, documenting infrastructure, evaluating, and performing quality management processes. This includes implementing an EDMS, supporting regulatory filings, managing Change Control and Change Management, and offering staff qualification and training services.
Read MoreService Providers
Our expertise extends to selecting, conducting due diligence, qualifying, and monitoring service providers, including vendors, CROs, CMOs, CTOs, and contract development organizations, ensuring compliance with GLP, GCLP, GCP, GMP, and analytical and process studies.
Read MoreNon-conformance and CAPAs
We recognize the criticality of addressing non-conformance events promptly. Our services include identifying root causes, implementing corrective actions, and establishing preventive measures through effective CAPA management to ensure continuous improvement and regulatory compliance.
Read MoreProduct Management
Our offerings cover the comprehensive Review and Monitoring, evaluation, and management of products throughout their lifecycle. This includes reviewing BPCRs, ensuring product quality and compliance, managing lot disposition, updating IBs, and overseeing manufacturing, packaging, labeling, and coding of investigational products.
Read MoreTesting by Our Expert Lab
Scientists
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