The Clinical Development Platform For Life Science Companies

Effortless cGxP document generation and management for the next generation of biotech

Focus on Innovation.
Let Us Handle the Paperwork.

Keeping biotech documentation under control shouldn’t be this hard. Teams waste countless hours managing compliance, tracking approvals, and fixing version control issues. Cytodyme takes the burden off your shoulders with an AI-powered system that streamlines your workflow so you can focus on advancing your research, not chasing paperwork.

Ditch the Document Hassle

Upload your existing documentation, and our AI organizes, updates, and ensures everything is accurate and cGMP ready.

Ditch the Document Hassle

Upload your existing documentation, and our AI organizes, updates, and ensures everything is accurate and cGMP ready.

Ditch the Document Hassle

Upload your existing documentation, and our AI organizes, updates, and ensures everything is accurate and cGMP ready.

Ditch the Document Hassle

Upload your existing documentation, and our AI organizes, updates, and ensures everything is accurate and cGMP ready.

Stay on Top of Compliance

No more version control headaches. Our system automatically generates and tracks your regulatory documents so your team always works with the latest information.

Stay on Top of Compliance

No more version control headaches. Our system automatically generates and tracks your regulatory documents so your team always works with the latest information.

Stay on Top of Compliance

No more version control headaches. Our system automatically generates and tracks your regulatory documents so your team always works with the latest information.

Stay on Top of Compliance

No more version control headaches. Our system automatically generates and tracks your regulatory documents so your team always works with the latest information.

Move Faster and Stay Focused

No more waiting weeks for approvals. Cytodyme helps your team collaborate, review, and finalize documentation efficiently, keeping your projects on track.

Move Faster and Stay Focused

No more waiting weeks for approvals. Cytodyme helps your team collaborate, review, and finalize documentation efficiently, keeping your projects on track.

Move Faster and Stay Focused

No more waiting weeks for approvals. Cytodyme helps your team collaborate, review, and finalize documentation efficiently, keeping your projects on track.

Move Faster and Stay Focused

No more waiting weeks for approvals. Cytodyme helps your team collaborate, review, and finalize documentation efficiently, keeping your projects on track.

Automatically Generate Regulatory Documents and Reports

Automatically Generate Regulatory Documents and Reports

Cytodyme’s AI-powered document generation creates SOPs, batch records, material specifications, and regulatory reports like IND submissions, change controls, and CAPAs. The platform extracts key data, applies formatting based on FDA and ISO requirements, and identifies missing documents. This reduces manual work from weeks to hours while ensuring full compliance

Cytodyme’s AI-powered document generation creates SOPs, batch records, material specifications, and regulatory reports like IND submissions, change controls, and CAPAs. The platform extracts key data, applies formatting based on FDA and ISO requirements, and identifies missing documents. This reduces manual work from weeks to hours while ensuring full compliance

Streamlined Docs. Seamless Onboarding.

Streamlined Docs. Seamless Onboarding.

Cytodyme makes clinical documentation fast, compliant and collaborative. We adhere to current regulatory standards including 21 CFR Part 11 while helping you import, version control, and manage your documents with ease. Get up and running in days—not months—with intuitive onboarding and a streamlined interface that lets your team focus on the science, not the systems.

Cytodyme makes clinical documentation fast, compliant and collaborative. We adhere to current regulatory standards including 21 CFR Part 11 while helping you import, version control, and manage your documents with ease. Get up and running in days—not months—with intuitive onboarding and a streamlined interface that lets your team focus on the science, not the systems.

Intelligent Compliance Validation & Missing Document Detection

Intelligent Compliance Validation & Missing Document Detection

Cytodyme analyzes your uploaded files and cross-references regulatory requirements to identify missing or incomplete documents. The system suggests AI-generated documents to fill in gaps and prevent costly delays in clinical trials and tech transfers.

Cytodyme analyzes your uploaded files and cross-references regulatory requirements to identify missing or incomplete documents. The system suggests AI-generated documents to fill in gaps and prevent costly delays in clinical trials and tech transfers.

Maximum Security & Compliance

Every document is securely managed with encryption, strict access controls, and audit trails. AI agents assist in structuring and organizing documents while keeping your data private and protected. Nothing is stored or used beyond its intended purpose, ensuring full compliance and control.

Cytodyme's platform is designed from the ground up to be compliant with all current good documumentation practices and regulatory standards. We are 21 CFR part 11, ISO 13485, ICH Q10, GxP, 21 CFR part 820 compliant. Cytodyme is constantly updating the platform to adhere to industry standard best practices.

Unwavering Regulatory Compliance

Cytodyme's platform is designed from the ground up to be compliant with all current good documumentation practices and regulatory standards. We are 21 CFR part 11, ISO 13485, ICH Q10, GxP, 21 CFR part 820 compliant. Cytodyme is constantly updating the platform to adhere to industry standard best practices.

Unwavering Regulatory Compliance

Cytodyme's platform is designed from the ground up to be compliant with all current good documumentation practices and regulatory standards. We are 21 CFR part 11, ISO 13485, ICH Q10, GxP, 21 CFR part 820 compliant. Cytodyme is constantly updating the platform to adhere to industry standard best practices.

Unwavering Regulatory Compliance

Cytodyme's platform is designed from the ground up to be compliant with all current good documumentation practices and regulatory standards. We are 21 CFR part 11, ISO 13485, ICH Q10, GxP, 21 CFR part 820 compliant. Cytodyme is constantly updating the platform to adhere to industry standard best practices.

Unwavering Regulatory Compliance

Cytodyme’s platform takes security seriously and follows modern security best practices. We use OAuth 2.0 and Two-Factor Authentication (2FA) for secure access control, and encrypt all data both in transit and at rest. Our infrastructure ensures strict tenant and network isolation, with intelligent rate limiting and anomaly detection to defend against abuse. We continuously monitor, audit, and test our systems to keep your data safe—so you can move fast without compromising security.

Enterprise Grade Security

Cytodyme’s platform takes security seriously and follows modern security best practices. We use OAuth 2.0 and Two-Factor Authentication (2FA) for secure access control, and encrypt all data both in transit and at rest. Our infrastructure ensures strict tenant and network isolation, with intelligent rate limiting and anomaly detection to defend against abuse. We continuously monitor, audit, and test our systems to keep your data safe—so you can move fast without compromising security.

Enterprise Grade Security

Cytodyme’s platform takes security seriously and follows modern security best practices. We use OAuth 2.0 and Two-Factor Authentication (2FA) for secure access control, and encrypt all data both in transit and at rest. Our infrastructure ensures strict tenant and network isolation, with intelligent rate limiting and anomaly detection to defend against abuse. We continuously monitor, audit, and test our systems to keep your data safe—so you can move fast without compromising security.

Enterprise Grade Security

Cytodyme’s platform takes security seriously and follows modern security best practices. We use OAuth 2.0 and Two-Factor Authentication (2FA) for secure access control, and encrypt all data both in transit and at rest. Our infrastructure ensures strict tenant and network isolation, with intelligent rate limiting and anomaly detection to defend against abuse. We continuously monitor, audit, and test our systems to keep your data safe—so you can move fast without compromising security.

Enterprise Grade Security

Every action is logged, tracked, and time-stamped to ensure a complete audit trail. Role-based access controls (RBAC) ensures users can only see and do what their role permits, minimizing risk and enforcing the principle of least privilege. From document creation to approval, version history and access logs provide full transparency—keeping your compliance records accurate, intact, and always ready for review.

Auditability & Strict Permissions

Every action is logged, tracked, and time-stamped to ensure a complete audit trail. Role-based access controls (RBAC) ensures users can only see and do what their role permits, minimizing risk and enforcing the principle of least privilege. From document creation to approval, version history and access logs provide full transparency—keeping your compliance records accurate, intact, and always ready for review.

Auditability & Strict Permissions

Every action is logged, tracked, and time-stamped to ensure a complete audit trail. Role-based access controls (RBAC) ensures users can only see and do what their role permits, minimizing risk and enforcing the principle of least privilege. From document creation to approval, version history and access logs provide full transparency—keeping your compliance records accurate, intact, and always ready for review.

Auditability & Strict Permissions

Every action is logged, tracked, and time-stamped to ensure a complete audit trail. Role-based access controls (RBAC) ensures users can only see and do what their role permits, minimizing risk and enforcing the principle of least privilege. From document creation to approval, version history and access logs provide full transparency—keeping your compliance records accurate, intact, and always ready for review.

Auditability & Strict Permissions

Cytodyme never stores customer documents on third-party services. All data is securely backed up with end-to-end encryption, and each customer is provisioned isolated storage buckets to ensure complete data separation. For teams with specific infrastructure needs, we also support hosting documents directly on your own systems—giving you full ownership.

Data Protection

Cytodyme never stores customer documents on third-party services. All data is securely backed up with end-to-end encryption, and each customer is provisioned isolated storage buckets to ensure complete data separation. For teams with specific infrastructure needs, we also support hosting documents directly on your own systems—giving you full ownership.

Data Protection

Cytodyme never stores customer documents on third-party services. All data is securely backed up with end-to-end encryption, and each customer is provisioned isolated storage buckets to ensure complete data separation. For teams with specific infrastructure needs, we also support hosting documents directly on your own systems—giving you full ownership.

Data Protection

Cytodyme never stores customer documents on third-party services. All data is securely backed up with end-to-end encryption, and each customer is provisioned isolated storage buckets to ensure complete data separation. For teams with specific infrastructure needs, we also support hosting documents directly on your own systems—giving you full ownership.

Data Protection

Affordable Plans that Scale With you

Cytodyme is designed to grow with your team at every stage of development. Whether you’re laying the foundation for compliance, scaling operations, or managing enterprise-level biotech workflows, our platform adapts to your needs. Each plan offers increasing levels of automation, integration, and regulatory support, ensuring you have the right tools at the right time.

All plans align with the latest regulatory standards, including FDA 21 CFR Part 11, ISO 13485, ICH Q10, GxP, FDA 21 CFR Part 820, and more, so you can stay compliant as you scale.

Discovery

For early-stage biotech teams establishing compliance foundations.

Stay organized from day one with document control, versioning, and cGMP-ready records, eliminating manual tracking.


Document Control

Versioning

QMS System

Data Management

Report Generation

cGMP Document Generation

Development

For growing biotech teams preparing for clinical trials and investment.

Optimize workflows with supplier and CDMO connections, while ensuring audit-ready documentation to meet investor and regulatory expectations.


Document Control

Versioning

QMS System

Data Management

Report Generation

cGMP Document Generation

Supplier Connection Tool

CDMO Connection Tool

Validate

For biotech teams navigating clinical trials and process validation.

Ensure regulatory alignment with electronic batch records and advanced compliance tools designed for scaling operations.


Document Control

Versioning

QMS System

Data Management

Report Generation

cGMP Document Generation

Supplier Connection Tool

CDMO Connection Tool

Electronic Batch Record

Enterprise

For large-scale biotech companies managing complex compliance needs.

Leverage full automation, security, and dedicated support to streamline commercialization and manufacturing at scale.


Document Control

Versioning

QMS System

Data Management

Report Generation

cGMP Document Generation

Supplier Connection Tool

CDMO Connection Tool

Electronic Batch Record

Construction & Real Estate

Dedicated CS Rep.

Advanced Security

Discovery

For early-stage biotech teams establishing compliance foundations.

Stay organized from day one with document control, versioning, and cGMP-ready records, eliminating manual tracking.


Document Control

Versioning

QMS System

Data Management

Report Generation

cGMP Document Generation

Development

For growing biotech teams preparing for clinical trials and investment.

Optimize workflows with supplier and CDMO connections, while ensuring audit-ready documentation to meet investor and regulatory expectations.


Document Control

Versioning

QMS System

Data Management

Report Generation

cGMP Document Generation

Supplier Connection Tool

CDMO Connection Tool

Validate

For biotech teams navigating clinical trials and process validation.

Ensure regulatory alignment with electronic batch records and advanced compliance tools designed for scaling operations.


Document Control

Versioning

QMS System

Data Management

Report Generation

cGMP Document Generation

Supplier Connection Tool

CDMO Connection Tool

Electronic Batch Record

Enterprise

For large-scale biotech companies managing complex compliance needs.

Leverage full automation, security, and dedicated support to streamline commercialization and manufacturing at scale.


Document Control

Versioning

QMS System

Data Management

Report Generation

cGMP Document Generation

Supplier Connection Tool

CDMO Connection Tool

Electronic Batch Record

Construction & Real Estate

Dedicated CS Rep.

Advanced Security

Discovery

For early-stage biotech teams establishing compliance foundations.

Stay organized from day one with document control, versioning, and cGMP-ready records, eliminating manual tracking.


Document Control

Versioning

QMS System

Data Management

Report Generation

cGMP Document Generation

Development

For growing biotech teams preparing for clinical trials and investment.

Optimize workflows with supplier and CDMO connections, while ensuring audit-ready documentation to meet investor and regulatory expectations.


Document Control

Versioning

QMS System

Data Management

Report Generation

cGMP Document Generation

Supplier Connection Tool

CDMO Connection Tool

Validate

For biotech teams navigating clinical trials and process validation.

Ensure regulatory alignment with electronic batch records and advanced compliance tools designed for scaling operations.


Document Control

Versioning

QMS System

Data Management

Report Generation

cGMP Document Generation

Supplier Connection Tool

CDMO Connection Tool

Electronic Batch Record

Enterprise

For large-scale biotech companies managing complex compliance needs.

Leverage full automation, security, and dedicated support to streamline commercialization and manufacturing at scale.


Document Control

Versioning

QMS System

Data Management

Report Generation

cGMP Document Generation

Supplier Connection Tool

CDMO Connection Tool

Electronic Batch Record

Construction & Real Estate

Dedicated CS Rep.

Advanced Security

Discovery

For early-stage biotech teams establishing compliance foundations.

Stay organized from day one with document control, versioning, and cGMP-ready records, eliminating manual tracking.


Document Control

Versioning

QMS System

Data Management

Report Generation

cGMP Document Generation

Development

For growing biotech teams preparing for clinical trials and investment.

Optimize workflows with supplier and CDMO connections, while ensuring audit-ready documentation to meet investor and regulatory expectations.


Document Control

Versioning

QMS System

Data Management

Report Generation

cGMP Document Generation

Supplier Connection Tool

CDMO Connection Tool

Validate

For biotech teams navigating clinical trials and process validation.

Ensure regulatory alignment with electronic batch records and advanced compliance tools designed for scaling operations.


Document Control

Versioning

QMS System

Data Management

Report Generation

cGMP Document Generation

Supplier Connection Tool

CDMO Connection Tool

Electronic Batch Record

Enterprise

For large-scale biotech companies managing complex compliance needs.

Leverage full automation, security, and dedicated support to streamline commercialization and manufacturing at scale.


Document Control

Versioning

QMS System

Data Management

Report Generation

cGMP Document Generation

Supplier Connection Tool

CDMO Connection Tool

Electronic Batch Record

Construction & Real Estate

Dedicated CS Rep.

Advanced Security

What Biotech Leaders are Saying

Biotechs are navigating a maze of documentation challenges, from regulatory compliance to manufacturing oversight. The inefficiencies are costly and time-consuming, but companies recognize the need for a better way. Here's what industry professionals are saying about why this solution matters.

Frequently Asked Questions

Get answers to the most important questions about how our platform simplifies biotech documentation, enhances compliance, and protects your data.

How does the platform help with regulatory compliance?
What types of documents can be generated?
Is my data secure and private?
How does document versioning and approval work?
Does the platform integrate with existing systems?
What is the onboarding process like?

Frequently Asked Questions

Get answers to the most important questions about how our platform simplifies biotech documentation, enhances compliance, and protects your data.

How does the platform help with regulatory compliance?
What types of documents can be generated?
Is my data secure and private?
How does document versioning and approval work?
Does the platform integrate with existing systems?
What is the onboarding process like?

Frequently Asked Questions

Get answers to the most important questions about how our platform simplifies biotech documentation, enhances compliance, and protects your data.

How does the platform help with regulatory compliance?
What types of documents can be generated?
Is my data secure and private?
How does document versioning and approval work?
Does the platform integrate with existing systems?
What is the onboarding process like?

Frequently Asked Questions

Get answers to the most important questions about how our platform simplifies biotech documentation, enhances compliance, and protects your data.

How does the platform help with regulatory compliance?
What types of documents can be generated?
Is my data secure and private?
How does document versioning and approval work?
Does the platform integrate with existing systems?
What is the onboarding process like?

See it in Action
Book a Demo Today

Discover how our platform simplifies regulatory workflows and accelerates your path to clinical success. Schedule a demo to see how it works.

See it in Action
Book a Demo Today

Discover how our platform simplifies regulatory workflows and accelerates your path to clinical success. Schedule a demo to see how it works.

See it in Action
Book a Demo Today

Discover how our platform simplifies regulatory workflows and accelerates your path to clinical success. Schedule a demo to see how it works.

See it in Action
Book a Demo Today

Discover how our platform simplifies regulatory workflows and accelerates your path to clinical success. Schedule a demo to see how it works.