Creating a proactive approach for your regulatory compliance needs. Compli understands this and why it’s so important to build a solid foundation of regulatory compliance into your organization’s mindset. With the increasing complexity of global manufacturing and the fluid state of regulator’s compliance expectations,. Compli can ease those challenges by identifying gaps in meeting compliance requirements and emphasizing the benefits of a robust quality culture in your organization.
So how do organizations meet ever changing quality standards mandated by US and other international regulators? Compli’s experienced team can provide mock observations and assessments mimicking various international regulatory entities. The results of these mock audits can be used by the client to improve their organization’s inspection readiness.
- Inspection Readiness & GxP Audits
Compli specializes in providing comprehensive compliance consulting services to help you meet the current and emerging regulatory demands and achieve compliance. Our team is dedicated to assisting you in preparing for regulatory agency audits, conducting internal audits, and advising on audit observations through remediation activities. Additionally, Compli can support you in preparing and executing supplier audit programs to meet your unique manufacturing requirements. These services include:
- Auditing (cGMP, Regulatory Certification, Supplier, Internal, Process)
- Standards assessments including gap analysis (EU Annex I, Data Integrity, 503B)
- Permanent Inspection readiness programs
- Assistance with Regulatory and other Competent Authority meetings (requesting, preparing for, and conducting)
- cGMP/GxP Training
- Quality Management Systems
Compli supports a range of life science clients from small start-up firms to large multinational pharmaceutical manufacturers. Compli can work within existing quality systems to refine and optimize to create a system from the ground up. We utilize best practices and industry standards for quality systems to reduce cost, risk, and customize for your unique requirements. The quality support services that Compli provides will save money and reduce risk. Services that Compli provides include:
- Quality Culture assessment, education, and deployment
- Quality Risk Management program development and implementation
- Quality Metrics program development and implementation
- Quality Investigations / CAPA Support / Deviation Handling / Root Cause Analysis
- GMP document development and assessments (SOP’s, Policies, Standards)
- Stability Management program development and implementation
Whether you have a small or large-scale project, Compli offers risk-based remediation services that can benefit your operations.
Our team of remediation professionals can organize and communicate the requirements of the remediation effort and leverage our experience to ensure success. Our professionals will identify and track every action item required for compliance remediation and escalate potential concerns to stakeholders and/or executive management for resolution. We partner with you to build your remediation plan, perform GAP assessments for all systems, and implement remediation efforts to meet your schedule and budget.
We understand the complexities associated with compliance constraints, manufacturing requirements and can support your organization to manage the remediation process to return your site to an efficient and compliant operation.