Arete Biosciences
A multidisciplinary partner for healthcare and life-science ventures that combines R&D, product development, industrial design, clinical operations, quality/regulatory strategy, and venture support. Offers end-to-end services from de-novo assay development and instrument engineering through pilot production and regulatory submissions, with embedded teams or fully outsourced engagement models.
Industries
Nr. of Employees
small (1-50)
Arete Biosciences
Carlsbad, California, United States
Products
Boutique CRO Services
Customized clinical trial planning, execution, vendor oversight, and study design aligned with regulatory and commercial objectives.
Quality Management System Support & Compliance
Scalable, audit-ready quality systems aligned with regulatory expectations and international standards.
Industrial Design and Human Factors Services
Comprehensive medical device design consultancy and human factors services blending styling, ergonomics, usability, and manufacturability from early discovery to detailed design and production transfer.
Regulatory Affairs
Targeted regulatory strategy and submission leadership for domestic and international markets.
Certified Auditing Services
Thorough analysis and guidance to strengthen quality systems, promote continuous improvement, and meet external audit goals.
Clinical Affairs
Strategic clinical guidance to strengthen development plans, study design, and submission packages for diagnostics.
Boutique CRO Services
Customized clinical trial planning, execution, vendor oversight, and study design aligned with regulatory and commercial objectives.
Quality Management System Support & Compliance
Scalable, audit-ready quality systems aligned with regulatory expectations and international standards.
Industrial Design and Human Factors Services
Comprehensive medical device design consultancy and human factors services blending styling, ergonomics, usability, and manufacturability from early discovery to detailed design and production transfer.
Regulatory Affairs
Targeted regulatory strategy and submission leadership for domestic and international markets.
Certified Auditing Services
Thorough analysis and guidance to strengthen quality systems, promote continuous improvement, and meet external audit goals.
Clinical Affairs
Strategic clinical guidance to strengthen development plans, study design, and submission packages for diagnostics.
Services
End-to-end product engineering for diagnostics and medical devices including assay development, consumable design, instrument engineering, embedded software, subsystem prototyping, and manufacturing readiness.
Concept development, CAD refinement, prototyping, packaging, labeling, IFU design, and human factors engineering to align user experience with regulatory requirements and manufacturability.
Clinical strategy and execution, custom clinical data systems, QMS development, regulatory strategy and submissions, verification/validation studies, and sample logistics.
Direct and in-kind investments, fundraising and investor support, business strategy, market mapping, IP/regulatory pathway guidance, incubation and execution support to align product milestones with funding objectives.
End-to-end product engineering for diagnostics and medical devices including assay development, consumable design, instrument engineering, embedded software, subsystem prototyping, and manufacturing readiness.
Concept development, CAD refinement, prototyping, packaging, labeling, IFU design, and human factors engineering to align user experience with regulatory requirements and manufacturability.
Clinical strategy and execution, custom clinical data systems, QMS development, regulatory strategy and submissions, verification/validation studies, and sample logistics.
Direct and in-kind investments, fundraising and investor support, business strategy, market mapping, IP/regulatory pathway guidance, incubation and execution support to align product milestones with funding objectives.
Expertise Areas
- Assay development and reagent formulation
- Microfluidic consumable and cartridge design
- Medical device and instrument engineering
- Embedded software and firmware for devices
Key Technologies
- Microfluidics
- Lyophilization of reagents
- Embedded firmware and device control
- Optical detection (fluorescence/absorbance)
News & Updates
In-vitro diagnostics (IVDs) in times of crisis: what manufacturers, labs and clinicians need to know
Discussion of regulatory guidance and operational considerations for IVDs during public health emergencies, focusing on FDA EUA frameworks.
Case narrative describing partnership to advance a multi-cancer test from prototype to clinical validation and planned CLIA-lab launch.
Article on embedded consulting models, benefits and implementation considerations for organizations engaging external teams as integrated resources.
In-vitro diagnostics (IVDs) in times of crisis: what manufacturers, labs and clinicians need to know
Discussion of regulatory guidance and operational considerations for IVDs during public health emergencies, focusing on FDA EUA frameworks.
Case narrative describing partnership to advance a multi-cancer test from prototype to clinical validation and planned CLIA-lab launch.
Article on embedded consulting models, benefits and implementation considerations for organizations engaging external teams as integrated resources.