Our Services
Biostatistical Analysis and Inference
- Application-specific statistical methodology development
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Manufacturing and testing specifications development
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Design of Experiment (DOE)
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Descriptive and inferential statistics
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Sample size estimation
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Statistical analysis plans and reports
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Regulatory submission support
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Failure Mode and Effects Analysis (FMEA)
Compliance Management and Regulatory Affairs
We are proud of our
100% success rate in FDA submissions!
The FDA has stringent requirements for ensuring that good quality assurance practices are used during the design and manufacturing of medical devices and drugs, and that they are consistent with global quality system standards. EmpiriQA helps our clients meet these compliance requirements by providing consulting services at every stage of the product development lifecycle, from concept to validation and FDA audits.
By combining product information, processes, personnel, technology, and industry standards, with product lifecycle management (PLM) technology, we ensure that our clients effectively and economically achieve compliance with FDA requirements. Our team possesses the necessary skills and experience in the following areas:
- Strategic planning
- 510(k) submissions
- IND/NDA submissions
- BLA submissions
- FDA and PAI inspection readiness
- Remediation strategies and implementation
- Regulatory liaison management, including participating in FDA audits on behalf of our clients
- Gap analyses of existing quality systems and compliance throughout the product life cycle
- Preparation for internal and external audits
- Gap analyses of existing quality systems and compliance throughout the product life cycle
- FDA-483 and Warning Letter responses
Quality Systems (QA/QC)
A robust quality system is integral for regulatory compliance for ensuring smooth inspections and audits as well as streamlining any identified corrective actions. EmpiriQA’s SMEs possess the qualifications and expertise for working within the highly regulated IVD, pharmaceutical, and medical device industries. We have a proven track record of assisting our clients in successfully managing their quality and regulatory compliance needs such that they conform to U.S. regulations and global standards including:
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Quality Systems Regulations (QSR)
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Good Laboratory Practice (GLP)
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Good Manufacturing Practice (GMP)
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International Organization for Standardization (ISO)
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Statistical Process Control (SPC)
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Six Sigma (6σ)
We work directly with our clients to understand their requirements, develop a plan of action in close association with company executives and technical staff, and execute that plan within time and budget constraints to achieve compliance goals. For 13 years, we have successfully assisted our clients in:
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Implementation of GxP quality systems and procedures
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Standard Operating Procedure (SOP) development and training
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Deviation and Out-of-Specification (OOS) investigations
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Corrective and Preventive Action (CAPA) planning and execution
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Batch record review and release
Design Control and Validation
EmpiriQA SMEs help our clients with design control solutions, from concept to transfer. Our SMEs will guide our clients through each phase of the product design process including:
- Establishment and maintenance of Design History Files (DHF)
- Validation, including preparation of protocols and final reports, field execution and data analysis:
- Design controls
- Manufacturing processes
- Laboratory and manufacturing equipment
- Analytical methods
- Computerized systems
- Facilities and utilities
- Design test requirements
- Validation specifications
- Design controls
Technical Expertise
- Medical device and pharmaceutical R&D
- Product / process design and optimization
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Immunodiagnostics and assay development
- Mathematical and computer / software modeling & simulation
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Manufacturing operations
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Biomedical, chemical, nuclear, and systems engineering applications
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Systems integration
- Public health applications
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Biotechnology and nanotechnology applications