Services

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Services2018-08-02T21:30:57+00:00
Computer Systems Validation

The FDA and other regulatory agencies have established criteria for software-based applications developed for use within the pharmaceutical, biological, and medical device industries. Focus personnel have experience with computer systems validation activities and provide services for a full range of validation deliverables, from Validation Plans through Validation Summary Reports.

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Services to the Medical Device Industry

Focus Compliance & Validation Services provides an extensive array of services for medical device companies to achieve compliance with 21 CFR Part 820 and ISO 13485. Focus has extensive expertise in providing consulting services in the areas of Quality System Regulation, Regulatory Compliance, Validation and Qualification Services, Risk Management, Computer System Validation, Response to Regulatory Body Actions, and On-Site Training.

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Regulatory Affairs and GXP Compliance

Focus provides innovative solutions to the FDA regulated industries. Our regulatory compliance specialists work closely with the FDA to ensure our clients have the latest information available and can quickly assess the impact of regulations. We offer our clients a unique blend of technical expertise, regulatory compliance insight, and practical hands-on operating experience. Focus has the resources to meet your project needs in the most cost-effective manner.

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Consulting Services to the Blood and Plasma Industry

Focus Compliance & Validation Services provides engineering and consulting services to the human blood and plasma collection industry. These services include the implementation of systems, procedures, and documentation to meet the FDA Quality System regulations affecting the blood and plasma industry. Focus has extensive expertise in providing consulting services in the area of Quality System Regulation, Regulatory Compliance, Validation and Qualification Services, Computer Validation, and On-Site Training.

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Consulting Services to the Pharmaceutical Packaging Industry

Focus Compliance & Validation Services provides engineering and consulting services to primary and contract pharmaceutical packaging companies. These services include the implementation of systems, procedures, and documentation to meet the FDA Quality System regulations affecting the packaging industry. Focus has extensive expertise in providing consulting services in the area of Quality System Regulation, Regulatory Compliance, Validation and Qualification Services, Computer Validation, and On-Site Training.

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Pharmaceutical Industry

Focus provides proven solutions to the FDA Regulated Pharmaceutical and Biotechnology Industries. Our compliance specialists work closely with our clients and the FDA to support the clients’ needs and requirements. We offer our clients a unique blend of technical expertise, compliance insight, and practical hands-on operating experience. Focus has the resources to meet your project needs in the most cost-effective manner.

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