About SymbioSIS Consulting
SymbioSIS Consulting LLC is a consulting organization based in West Lafayette, Indiana. The company has significant experience in MedTech research and development, regulatory strategy, and lean manufacturing strategies. Recent projects include realizing R&D portfolios, especially in support of regulatory pathways for regenerative devices. SymbioSIS Consulting provides fractional leadership, strategic reviews, and embedded technical consulting for startups and mid-sized medical device innovators.
Services
SymbioSIS Consulting provides the services listed below.
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Regulatory Support
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R&D Services
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Tissue Engineering Research
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CDMO Connector
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Project Management Support
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ISO 13485 Compliance
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ISO 14971 Compliance
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ISO 22442 Compliance
Life Science Expertise
Industries Supported
SymbioSIS Consulting supports the life science industries listed below.
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Medical Devices and MedTech
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Pharmaceuticals
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Biotechnology
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Contract Research Organizations (CROs)
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Contract Development and Manufacturing Organizations (CDMOs)
Regulatory, Quality, and Compliance Expertise
SymbioSIS Consulting has relevant expertise in the areas outlined below.
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ISO 13485
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ISO 14971
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ISO 22442 series
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EU GMP Annex 1
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GxP
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21 CFR Part 820
Countries and Markets Served
SymbioSIS Consulting serves clients in the countries and markets listed below.
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United States
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Canada
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Australia
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European Union
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United Kingdom
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Asia-Pacific
How SymbioSIS Consulting Works with SimplerQMS
SymbioSIS Consulting works with SimplerQMS to support medical device and life science organizations that need to implement an electronic quality management system. The company can assist with onboarding a new eQMS and setting up the system structure to maximize client success and FDA submission preparedness.
Join the SimplerQMS Partner Network
Expand your services and explore new collaboration opportunities with an eQMS provider focused on life sciences.
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