CQV SERVICES
Commissioning, Qualification and Validation
From planning to execution to verification and beyond, we bring expertise in solving the challenges of each Lifecycle phase starting with delineating the “user requirements” for the facility and/or systems to fully validated and continuous monitoring systems to maintain the regulated status
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CQV PROJECTS SUMMARIES
Qualification and Validation services
C&A provides Qualification and Validation services in full compliance with cGMP standards, with integration of modern CQV strategies and using/implementing risk-based approaches to process validation and writing all client’s SOPs. The Qualification and Validation of process equipment
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AUDITING REGULATORY COMPLIANCE
QUALITY SERVICES & REGULATORY COMPLIANCE
C&A Regulatory Affairs specialists provide valuable aid in assisting clients to prepare the regulatory filing and submissions and ensure inspection readiness of the manufacturing site. We are qualified to interfere with various levels of the projects and interface with the regulators as we navigate
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Why Cius & Associates, LLC
Cius &Associates (C&A) provides consulting and engineering services to the Bio-Pharmaceutical industry from Commissioning & Qualification to Validation (CQ&V) and Project Management to our clients across the USA, Canada, Europe and the MENA region. The services extend to commercialization readiness, including process development and cleaning validation, with a strong capability to develop high-quality documents assisting clients and their projects.
- Project Management Services
C&A offer integrated project management services and methodology, supported and reflected by our experience and policies. - Qualification and Validation Services
C&A are well-versed in developing and implementing risk-based approaches to validation - Engineering Services
C&A supports engineering services & phase of the “GEP Lifecycle” from planning for new products to retirement of equipment. - Process Development Services
C&A process development experience comes from supporting the cGMP manufacturing of bulk drug substances (BDS) for many clients. - Auditing Regulatory Services
C&A offers Regulatory and QA services and Quality Management Systems and ensures readiness for regulatory inspections