SCIE Solutions
End-to-end operations, quality, and regulatory expertise for health tech companies at every stage of growth.
About SCIE Solutions
SCIE Solutions was founded in 2007 with the mission to “Help people build companies that help improve the lives of others”. SCIE Solution provides its clients access to seasoned professionals with proven track record of addressing the unique industry complexities of business creation, product development and product realization activities required to successfully navigate the health tech road map from ideation through product commercialization.
SCIE’s vision is to provide our partners with end-to-end Operations, Quality, and Supply Chain management support at every stage of the company’s development from concept through commercialization. SCIE Solutions offers a wide range of services enabling our partners to focus their internal resources on their customers while the SCIE Solutions team manages their Operations and global Supply Chain network to ensure strategic objectives on service levels, risk management, price competitiveness and quality are achieved.
Sourcing & Procurement
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Supplier Management Program– Auditing, Scorecards, reporting, trend monitoring and quality
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Supplier Quality Management – Program establishment or complete outsourcing.
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Strategic Sourcing – Leverage unique product materials, process, IP and Strategic Partnerships e
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Supplier Risk Management Initiative – Identity, Mitigate, Monitor and Execute Risk Strategy
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Supplier Asset Management – Auditing, financial reporting, tracking and risk management
Project Management
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Operations New Product Introduction, Product transfers, site relocations, and new facilities implementations
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Due diligence acquisitions and integrations
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Dual sourcing project management from alternative vendor selection to tech transfer
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ERP Implementations and Validation
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Lean Manufacturing and Six Sigma implementations
Quality
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Quality Management System implementation and integrations (QMSR, ISO13485:2016, ISO9001:2015, MDSAP, EU MDR preparations, Notified Body transfers/consolidations)
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QMS Internal Auditing Services – Annual compliance and mock external audit preparations.
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Electronic QMS integrations, validations, and implementations (single site, multiple systems, multi-sites, transfers from paper to electronic systems)
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Quality Assurance & Quality Systems Facilitation (Management Review, Document Control, Training, CAPA, Remediations, Supplier Quality Management)
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Quality Training – Process and Procedure Development, Basic and Advanced cGMP training.
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Field Services (Complaint management, Regulatory reporting, Field Action management, Customer Service)
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Risk Management and Post-Market Surveillance (Complaint management, Regulatory reporting, Field Action)
Clinical/Regulatory Affairs
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Technical Files/Design Dossiers: Generation, Maintenance and Remediations
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Regulatory Submissions, Regulatory Strategy Development, New Product Introduction Support
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Global Regulatory Filings: 510(k)s, PMAs, NDAs, ANDAs, INDs, BLAs, IDEs, EUAs, CE mark, and other regulatory filings
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Global Product Registrations and Labeling
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Auditing: GCP
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Clinical Evaluation Reporting (CER)
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Clinical Trial Management and Study Design
Solutions By Regulatory Standard
AS9100
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HACCP
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IATF 16949
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SQF
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