Our Advisory Board
Our Advisory Board brings together leading experts in medicine, law, and business who guide Skydell Medical’s vision, ensure regulatory integrity, and support the growth of a trusted, compliant healthcare ecosystem.
Master the Science of Biologic Quality & Compliance
Explore policy-informed education focused on biologic science, regulatory frameworks, and quality standards.
Master the Science of Biologic
Quality & Compliance
Explore policy-informed education focused on biologic science,
regulatory frameworks, and quality standards.
Explore Educational Resources
Policy-Informed Professional Education
Don't just follow standards—set them. Our team includes the architects of Florida's stem cell legislation, providing
clarity around regulatory structure, scientific context, and compliance considerations.
Policy-Informed Professional Education
Don't just follow standards—set them. Our team includes the architects of Florida's stem cell legislation, providing clarity around regulatory structure, scientific context, and compliance considerations.
Legislation-Informed Scientific Education
Advance your understanding of biologic science through webinars and educational programs developed by professionals involved in regulatory policy, accreditation standards, and biologic classification frameworks, supported by AATB-accredited laboratory practices.
Regulatory & Legislative Frameworks
Education covering the laws, policies, and regulatory considerations governing biologic materials, including HCT/P classification and compliance requirements.
Cellular Characterization & Quality Metrics
Instruction on laboratory methods used to assess cell populations, viability metrics, and post-processing characterization standards.
Biologic Processing & Laboratory Standards
Overview of processing methodologies, handling considerations, and quality benchmarks applied within accredited and registered laboratory environments.
Extracellular Vesicle & Secretome Science
Foundational education on extracellular vesicles and secretome composition, including analytical characterization and classification terminology.
Our Advisory Board
Our Advisory Board brings together leading experts in medicine, law, and business who guide Skydell Medical’s vision, ensure regulatory integrity, and support the growth of a trusted, compliant healthcare ecosystem.
Legislation-Informed Scientific Education
Advance your understanding of biologic science through webinars and educational programs developed by professionals involved in
regulatory policy, accreditation standards, and biologic classification frameworks, supported by AATB-accredited laboratory practices.
Regulatory & Legislative
Frameworks
Education covering the laws, policies, and regulatory considerations governing biologic materials, including HCT/P classification and compliance requirements.
Cellular Characterization &
Quality Metrics
Instruction on laboratory methods used to assess cell populations, viability metrics, and post-processing characterization standards.
Biologic Processing & Laboratory Standards
Overview of processing methodologies, handling considerations, and quality benchmarks applied within accredited and registered laboratory environments.
Extracellular Vesicle &
Secretome Science
Foundational education on extracellular vesicles and secretome composition, including analytical characterization and classification terminology.
AATB-Accredited Facilities.
FDA-Registered Laboratories.
We provide documented laboratory data and accreditation information to support transparency around
biologic sourcing, processing environments, and analytical testing methodologies.
AATB-Accredited Facilities. FDA-Registered Laboratories.
We provide documented laboratory data and accreditation information to support transparency around biologic sourcing, processing environments, and analytical testing methodologies.
Legislative & Scientific Context
Educational resources addressing regulatory definitions, compliance frameworks, and accreditation standards applicable to biologic materials, informed by contributors involved in policy development and laboratory governance.
The Skydell Compliance Framework
All biologic materials are accompanied by lot-specific documentation generated by FDA-registered, third-party laboratories and processed within AATB-accredited facilities, in alignment with established safety and quality benchmarks.
Extracellular Vesicle & Nanoparticle Analysis
Foundational education on extracellular vesicles and nanoparticle measurement, including analytical reporting practices and concentration metrics.
Regulatory Alignment
Educational materials emphasize adherence to applicable federal, state, and accreditation requirements governing biologic materials and laboratory operations.
Documented Viability Metrics
Laboratory reports include post-processing viability data as measured by standardized analytical methods, provided for informational and educational reference.
Cell Population Characterization
Educational review of mononuclear, mesenchymal, and hematopoietic cell populations, including laboratory identification methods and characterization standards.
Minimally Manipulated HCT/P Classification
Overview of regulatory criteria, terminology, and classification principles applicable to minimally manipulated HCT/Ps under current federal guidelines.
Meet the Minds Behind the Law
From State Legislation to Regulatory Education
Watch Dr. Felix Lurye and members of the legislative team discuss the development of biologic-related legislation, the intent behind regulatory
frameworks, and the role of AATB-accredited laboratories in maintaining standardized processing and documentation practices.
Legislative & Scientific Context
Educational resources addressing regulatory definitions, compliance frameworks, and accreditation standards applicable to biologic materials, informed by contributors involved in policy development and laboratory governance.
The Skydell Compliance Framework
All biologic materials are accompanied by lot-specific documentation generated by FDA-registered, third-party laboratories and processed within AATB-accredited facilities, in alignment with established safety and quality benchmarks.
Extracellular Vesicle & Nanoparticle Analysis
Foundational education on extracellular vesicles and nanoparticle measurement, including analytical reporting practices and concentration metrics.
Regulatory Alignment
Educational materials emphasize adherence to applicable federal, state, and accreditation requirements governing biologic materials and laboratory operations.
Documented Viability Metrics
Laboratory reports include post-processing viability data as measured by standardized analytical methods, provided for informational and educational reference.
Cell Population Characterization
Educational review of mononuclear, mesenchymal, and hematopoietic cell populations, including laboratory identification methods and characterization standards.
Minimally Manipulated HCT/P Classification
Overview of regulatory criteria, terminology, and classification principles applicable to minimally manipulated HCT/Ps under current federal guidelines.
Meet the Minds
Behind the Law
From State Legislation to
Regulatory Education
Watch Dr. Felix Lurye and members of the legislative team discuss the development of biologic-related legislation, the intent behind regulatory frameworks, and the role of AATB-accredited laboratories in maintaining standardized processing and documentation practices.
Evidence-Informed Educational Rounds
Access a curated library of educational webinars, scientific literature summaries, and reference materials focused on biologic science, regulatory context, and laboratory characterization standards.
Evidence-Informed Educational Rounds
Access a curated library of educational webinars, scientific literature summaries, and reference materials focused on biologic science, regulatory context, and laboratory characterization standards.
Access Provider Portal
Practitioner-Only Biologic Materials Catalog
Secure, provider-restricted access to acellular and cellular biologic materials, accompanied by laboratory documentation and accreditation information, made available to qualified professionals for educational, research, and regulatory-compliant procurement purposes.
Practitioner-Only Biologic Materials Catalog
Secure, provider-restricted access to acellular and cellular biologic materials, accompanied by laboratory documentation and accreditation information, made available to qualified professionals for educational, research, and regulatory-compliant procurement purposes.
View All Products
Our Team. Our Labs. Our Standards.
Led by professionals involved in biologic policy development and laboratory governance, we work exclusively with FDA-registered laboratories and AATB-accredited facilities to maintain consistent documentation, processing oversight, and quality benchmarks.
Legislator-Informed Educational Webinars
AATB-Accredited Processing Facilities
FDA-Registered Laboratory Environments
Lot-Specific Third-Party Certificates of Analysis (COAs)
Documentation & Compliance Guidance.
View All Products
Our Team. Our Labs. Our Standards.
Led by professionals involved in biologic policy development and laboratory governance, we work exclusively with FDA-registered laboratories and AATB-accredited facilities to maintain consistent documentation, processing oversight, and quality benchmarks.
Legislator-Informed Educational Webinars
AATB-Accredited Processing Facilities
FDA-Registered Laboratory Environments
Lot-Specific Third-Party Certificates of Analysis (COAs)
Documentation & Compliance Guidance.
Nanoparticle Measurement Data
Third-party laboratory–reported concentration metrics.
AATB-Accredited Facilities
Processing environments meeting accreditation requirements.
Provider-Only Educational Access
Verified professional discussions and scientific exchange.
Post-Processing Viability Data
Laboratory-reported viability results for reference.
Legislative & Regulatory Context
Educational insight into applicable compliance frameworks.
ISO-7 Cleanroom Standards
Controlled laboratory conditions for material handling.
AABB & AATB Benchmarks
Alignment with recognized safety and quality standards.
Practice Operations Education
Non-clinical resources on compliance and administration.
Your Path to Professional Education
A structured onboarding experience designed to provide regulated access to educational resources, laboratory documentation, and professional materials, informed by contributors involved in biologic policy and accreditation.
Your Path to Professional Education
A structured onboarding experience designed to provide regulated access to educational resources, laboratory documentation, and professional materials, informed by contributors involved in biologic policy and accreditation.
Step - 1
Credential Verification
Provider-only access through license or credential confirmation.
Step - 2
Educational Rounds
Access webinars and materials on regulatory frameworks and biologic science.
Step - 3
Practice Scale-Up
Review compliance-related documentation and professional resources.
Step - 4
Precision Fulfillment
View biologic materials with accreditation records and lot-specific documentation.
Step - 1
Credential Verification
Provider-only access through license or credential confirmation.
Step - 2
Educational Rounds
Access webinars and materials on regulatory frameworks and biologic science.
Step - 3
Practice Scale-Up
Review compliance-related documentation and professional resources.
Step - 4
Precision Fulfillment
View biologic materials with accreditation records and lot-specific documentation.
Skydell Clinical Grand Rounds
Join live sessions led by Dr. Felix Lurye and the clinicians who architected regenerative legislation to master AATB-certified protocols.
Exosomes: Mechanisms, Applications, and Compliance
Understanding exosome biology, regulatory considerations, and clinical relevance.
Speaker:
Dr. Michael Turner, PhD
Clinical Research Advisor
Know More
Therapeutic Peptides: Clinical Use and Safety Standards
An overview of peptide categories, usage frameworks, and compliance best practices.
Speaker:
Dr. Emily Carter, MD
Medical Advisory Team Know More
Stem Cells – Science, Use Cases & Compliance
An Educational Webinar Exploring Stem Cell Fundamentals, Applications, and Regulatory Insights.
Speakers:
Dr. Felix Lurye & Lisa Speer
Medical Advisory Team Know More
Skydell Grand Rounds & Live Training
Join Dr. Felix Lurye for expert-led deep dives into advanced biologic applications.
Stem Cells – Science, Use Cases & Compliance
An Educational Webinar Exploring Stem Cell Fundamentals, Applications, and Regulatory Insights.
Speakers:
Dr. Felix Lurye & Lisa Speer
Medical Advisory Team
Know More
Frequently Asked Questions
Biologic materials are sourced through accredited programs and are accompanied by documentation demonstrating adherence to applicable FDA, AABB, and AATB requirements, as verified by third-party laboratories.
Skydell provides access to educational resources, regulatory context, and laboratory documentation for qualified professionals. Skydell does not engage in patient-facing activities or clinical decision-making.
Post-processing viability metrics are generated by independent, FDA-registered laboratories and provided as part of lot-specific documentation for informational and reference purposes.
No. Content available through this platform is limited to scientific, regulatory, and laboratory-related information and does not include treatment guidance, clinical claims, or outcome-based representations.
Frequently Asked Questions
Biologic materials are sourced through accredited programs and are accompanied by documentation demonstrating adherence to applicable FDA, AABB, and AATB requirements, as verified by third-party laboratories.
Skydell provides access to educational resources, regulatory context, and laboratory documentation for qualified professionals. Skydell does not engage in patient-facing activities or clinical decision-making.
Post-processing viability metrics are generated by independent, FDA-registered laboratories and provided as part of lot-specific documentation for informational and reference purposes.
No. Content available through this platform is limited to scientific, regulatory, and laboratory-related information and does not include treatment guidance, clinical claims, or outcome-based representations.
