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Services
CSI provides the full spectrum of services and support throughout the process life cycle compliant with U.S. 21 CFR Part 11.
Regulatory Compliance
- Strategic Planning & Risk Assessment
- Validation Services
- Software systems
- Laboratory information management systems
- Clinical trial software
- Databases
- Instrument Qualification – IQ, OQ, PQ
- Laboratory Facility Validation [link to pdf Validation Brochure]
- Preapproval Inspection Preparation
- GLP compliance
- GMP compliance
- GCP compliance
- Auditing services
- Bioanalytical Method Validation
- Compliance with 21 CFR Part 11
- Training
- GLP, GMP or GCP training tailored for your organization)
Regulatory Submissions
Do you have a global strategy for bringing your product to market? Does your development plan address the regulatory requirements to achieve approval in all of the countries in which you want to sell product? Our consulting services can help you develop a global regulatory plan.
- Premarket approval strategies for medical devices
- Global Regulatory Plan
- Develop strategy for FDA approval
- Develop strategy for other government approvals such as in Canada, Europe, Japan and China
- Preparation of FDA submissions for medical devices
- Investigational Device Exemption - IDE
- Premarket notification - 510(k)
- Premarket approval application – PMA
- Preparing for meetings with FDA
- ?? Preparation of FDA submissions for drugs and biologics
Clinical Trials
- Good Clinical Practice Audits
- GCP Training
- Clinical trial monitoring?
- Clinical protocol review and/or preparation
- Case report form design and preparation
- Specimen Collection, Processing & Distribution
- Consent form preparation
- IRB approval process
- Investigator Brochures
- Clinical Site Qualification
Below is from old website
Regulatory Compliance / QA Consulting
Regulatory Submissions
Clinical Trial Management
Details
Regulatory Compliance / QA Consulting
Risk Assessment / Gap Analysis
CSI can provide a risk assessment for your organization that will identify existing compliance, strategic and operational risks for Management. Compliance risks are issues that could lead to an audit finding of non-compliance with applicable regulations. Strategic risks arise if an audit uncovers noncompliance or an unacceptable operation, which could result in a loss of business and a negative reputation. Additionally, operational risks involve such issues as inefficient use of resources and unnecessary costs.
Vendor Auditing
CSI has performed numerous audits of vendors of software products, contract service companies, technology service providers, clinical laboratories and data management organizations on behalf of our domestic and global pharmaceutical, biotechnology and contract laboratory clients. The audits were performed to determine the level of compliance with FDA regulations and guidance regarding computer system validation, GLP/GCP/GMP requirements, and 21 CFR Part 11, and to minimize business and technical risks to the purchaser. These audits are formally documented in vendor audit reports with extensive and detailed recommendations for corrective action, including reference to the relevant regulations and guidance.
Remediation Planning / Monitoring
Our regulatory compliance assessments and vendor audits often result in numerous findings and recommendations. CSI has been successful in assuring a complete and thorough completion of the identified remediation tasks and sub-projects. We have assisted both the sponsors and vendors in assuring that all regulatory compliance issues are adequately resolved through a structured process of planning, progress monitoring and reporting.
Quality Management and Compliance Consulting
CSI services include quality management and compliance consulting to assist companies with the development or improvement of quality assurance, quality control and quality management processes, procedures and controls. CSI can provide expert reviews of validation strategies, development methodologies, company policies, procedures and techniques. We can either provide our recommendations in a formal report that provides strategic and tactical improvements in policies, procedures and documentation, or our trained personnel can write missing or deficient quality management documents.
Scientific Writing (SOPs, validation reports, regulatory reports)
CSI development services begin with an audit of the existing SOPs. After establishing what your specific needs are, we can develop custom or generic SOPs specifically for the respective organization, process or system.
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Regulatory Submissions
Clinical Trial Management
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