Management of GMP/Compliance Situations

Ensuring GMP and Compliance: Management of GMP/Compliance Situations Our services encompass the management of GMP (Good Manufacturing Practice) and compliance situations, providing clients with comprehensive support in maintaining and improving their manufacturing processes and compliance standards. Our experienced team specializes in identifying and addressing GMP and compliance issues, ensuring adherence to regulatory requirements and industry […]

Vendor Qualification, Inspections and Mock Pre-approval Audits

Ensuring Quality Partnerships: Vendor Qualification, Inspections, and Mock Pre-Approval Audits Our services encompass vendor qualification, inspections, and mock pre-approval audits, ensuring that clients establish and maintain partnerships with high-quality suppliers and meet regulatory requirements. We conduct thorough vendor qualification assessments to evaluate potential suppliers based on their capabilities, quality systems, compliance history, and suitability for […]

Design, Implementation and Remediation of Quality Systems

Building Strong Foundations: Design, Implementation, and Remediation of Quality Systems Our services encompass the design, implementation, and remediation of quality systems, helping clients establish robust frameworks to ensure quality, compliance, and continuous improvement. Our experienced team works closely with clients to design custom quality systems tailored to their specific industry, regulatory requirements, and business objectives. […]

Gap assessments, PAI readiness, Audits

Strengthening Quality Assurance: Gap Assessments, PAI Readiness, Audits Our services encompass conducting comprehensive gap assessments, preparing for Pre-Approval Inspections (PAI) readiness, and performing audits, enabling clients to strengthen their quality assurance processes and ensure compliance. Our experienced team conducts thorough gap assessments to identify areas of non-compliance, inefficiencies, and opportunities for improvement in quality systems […]