The Clinical Development Platform For Life Science Companies
Effortless regulatory and compliance documentation 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 on administrative burdens like tracking approvals, fixing version control issues, reviewing literature, and managing complaints. Cytodyme takes the burden off your shoulders with an AI-powered system that streamlines your workflows so you can focus on innovation, not chasing paperwork.
Ditch the Document Hassle
Cytodyme integrates with your company’s existing systems and helps create the reports and documentation regulatory bodies require.
Ditch the Document Hassle
Cytodyme integrates with your company’s existing systems and helps create the reports and documentation regulatory bodies require.
Ditch the Document Hassle
Cytodyme integrates with your company’s existing systems and helps create the reports and documentation regulatory bodies require.
Ditch the Document Hassle
Cytodyme integrates with your company’s existing systems and helps create the reports and documentation regulatory bodies require.
Stay on Top of Compliance
Cytodyme uses AI to automatically scan your documents to flag issues and ensure everything is compliant with relevant standards
Stay on Top of Compliance
Cytodyme uses AI to automatically scan your documents to flag issues and ensure everything is compliant with relevant standards
Stay on Top of Compliance
Cytodyme uses AI to automatically scan your documents to flag issues and ensure everything is compliant with relevant standards
Stay on Top of Compliance
Cytodyme uses AI to automatically scan your documents to flag issues and ensure everything is compliant with relevant standards
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.
A Unified Solution for Complaint Management
A Unified Solution for Complaint Management
Cytodyme’s AI-powered platform manages complaint intakes, completes risk assessments, generate response letters and MDR reports, while tracking surfacing trends.
Cytodyme’s AI-powered platform manages complaint intakes, completes risk assessments, generate response letters and MDR reports, while tracking surfacing trends.
Post-Market Surveillance with Automatic Literature Search and Review
Post-Market Surveillance with Automatic Literature Search and Review
Cytodyme can simultaneously search across multiple literature databases to identify, select, and review relevant studies for reports such as PSUR, PMPFR, SOTA, etc.
Cytodyme can simultaneously search across multiple literature databases to identify, select, and review relevant studies for reports such as PSUR, PMPFR, SOTA, etc.
A Simplified QMS
A Simplified QMS
We’ve built a Lean QMS that is intuitive, simple and easy to use. Onboard in days, not months.
We’ve built a Lean QMS that is intuitive, simple and easy to use. Onboard in days, not months.
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 meet 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.
Starter
For early teams laying the groundwork for preclinical and clinical development.
This tier provides the essential tools to organize documentation, follow structured workflows, and stay aligned with basic regulatory expectations while the program is still taking shape.
Growth
For biotech teams moving into clinical trials and building out more formal processes.
This tier supports stronger compliance needs, introduces automation for key documentation tasks, and helps teams stay coordinated as programs expand and timelines accelerate.
Enterprise
For larger organizations preparing for late-stage development and regulatory submissions.
This tier is built for scale, offering advanced workflow capabilities, broader process oversight, and the support needed to maintain audit readiness across complex teams and multiple programs.
Starter
For early teams laying the groundwork for preclinical and clinical development.
This tier provides the essential tools to organize documentation, follow structured workflows, and stay aligned with basic regulatory expectations while the program is still taking shape.
Growth
For biotech teams moving into clinical trials and building out more formal processes.
This tier supports stronger compliance needs, introduces automation for key documentation tasks, and helps teams stay coordinated as programs expand and timelines accelerate.
Enterprise
For larger organizations preparing for late-stage development and regulatory submissions.
This tier is built for scale, offering advanced workflow capabilities, broader process oversight, and the support needed to maintain audit readiness across complex teams and multiple programs.
Starter
For early teams laying the groundwork for preclinical and clinical development.
This tier provides the essential tools to organize documentation, follow structured workflows, and stay aligned with basic regulatory expectations while the program is still taking shape.
Growth
For biotech teams moving into clinical trials and building out more formal processes.
This tier supports stronger compliance needs, introduces automation for key documentation tasks, and helps teams stay coordinated as programs expand and timelines accelerate.
Enterprise
For larger organizations preparing for late-stage development and regulatory submissions.
This tier is built for scale, offering advanced workflow capabilities, broader process oversight, and the support needed to maintain audit readiness across complex teams and multiple programs.
Starter
For early teams laying the groundwork for preclinical and clinical development.
This tier provides the essential tools to organize documentation, follow structured workflows, and stay aligned with basic regulatory expectations while the program is still taking shape.
Growth
For biotech teams moving into clinical trials and building out more formal processes.
This tier supports stronger compliance needs, introduces automation for key documentation tasks, and helps teams stay coordinated as programs expand and timelines accelerate.
Enterprise
For larger organizations preparing for late-stage development and regulatory submissions.
This tier is built for scale, offering advanced workflow capabilities, broader process oversight, and the support needed to maintain audit readiness across complex teams and multiple programs.
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.
VP QA
We looked into other electronic QMS software, but they charge $20,000 just to write 10 SOPs, and then they charge an extra $10,000 per year just for hosting version control. It just doesn’t make sense for startups.
R&D Director
My biggest challenge with automation tools is that I don’t see anyone using them to their full potential. I have to move into automation, but it requires a lot of cross-organizational talking, and we don’t have the time to learn.
BD Executive
No one wants to be just filtering through documentation for hours at a time. It’s not the best use of anyone’s skill set, and it slows everything down. This tool can streamline that process and make sure everything’s where it needs to be, that’s a big win.
VP QA
We looked into other electronic QMS software, but they charge $20,000 just to write 10 SOPs, and then they charge an extra $10,000 per year just for hosting version control. It just doesn’t make sense for startups.
R&D Director
My biggest challenge with automation tools is that I don’t see anyone using them to their full potential. I have to move into automation, but it requires a lot of cross-organizational talking, and we don’t have the time to learn.
BD Executive
No one wants to be just filtering through documentation for hours at a time. It’s not the best use of anyone’s skill set, and it slows everything down. This tool can streamline that process and make sure everything’s where it needs to be, that’s a big win.
VP QA
We looked into other electronic QMS software, but they charge $20,000 just to write 10 SOPs, and then they charge an extra $10,000 per year just for hosting version control. It just doesn’t make sense for startups.
R&D Director
My biggest challenge with automation tools is that I don’t see anyone using them to their full potential. I have to move into automation, but it requires a lot of cross-organizational talking, and we don’t have the time to learn.
BD Executive
No one wants to be just filtering through documentation for hours at a time. It’s not the best use of anyone’s skill set, and it slows everything down. This tool can streamline that process and make sure everything’s where it needs to be, that’s a big win.
VP QA
We looked into other electronic QMS software, but they charge $20,000 just to write 10 SOPs, and then they charge an extra $10,000 per year just for hosting version control. It just doesn’t make sense for startups.
R&D Director
My biggest challenge with automation tools is that I don’t see anyone using them to their full potential. I have to move into automation, but it requires a lot of cross-organizational talking, and we don’t have the time to learn.
BD Executive
No one wants to be just filtering through documentation for hours at a time. It’s not the best use of anyone’s skill set, and it slows everything down. This tool can streamline that process and make sure everything’s where it needs to be, that’s a big win.
VP QA
We looked into other electronic QMS software, but they charge $20,000 just to write 10 SOPs, and then they charge an extra $10,000 per year just for hosting version control. It just doesn’t make sense for startups.
R&D Director
My biggest challenge with automation tools is that I don’t see anyone using them to their full potential. I have to move into automation, but it requires a lot of cross-organizational talking, and we don’t have the time to learn.
BD Executive
No one wants to be just filtering through documentation for hours at a time. It’s not the best use of anyone’s skill set, and it slows everything down. This tool can streamline that process and make sure everything’s where it needs to be, that’s a big win.
VP QA
We looked into other electronic QMS software, but they charge $20,000 just to write 10 SOPs, and then they charge an extra $10,000 per year just for hosting version control. It just doesn’t make sense for startups.
R&D Director
My biggest challenge with automation tools is that I don’t see anyone using them to their full potential. I have to move into automation, but it requires a lot of cross-organizational talking, and we don’t have the time to learn.
BD Executive
No one wants to be just filtering through documentation for hours at a time. It’s not the best use of anyone’s skill set, and it slows everything down. This tool can streamline that process and make sure everything’s where it needs to be, that’s a big win.
VP QA
We looked into other electronic QMS software, but they charge $20,000 just to write 10 SOPs, and then they charge an extra $10,000 per year just for hosting version control. It just doesn’t make sense for startups.
R&D Director
My biggest challenge with automation tools is that I don’t see anyone using them to their full potential. I have to move into automation, but it requires a lot of cross-organizational talking, and we don’t have the time to learn.
BD Executive
No one wants to be just filtering through documentation for hours at a time. It’s not the best use of anyone’s skill set, and it slows everything down. This tool can streamline that process and make sure everything’s where it needs to be, that’s a big win.
VP QA
We looked into other electronic QMS software, but they charge $20,000 just to write 10 SOPs, and then they charge an extra $10,000 per year just for hosting version control. It just doesn’t make sense for startups.
R&D Director
My biggest challenge with automation tools is that I don’t see anyone using them to their full potential. I have to move into automation, but it requires a lot of cross-organizational talking, and we don’t have the time to learn.
BD Executive
No one wants to be just filtering through documentation for hours at a time. It’s not the best use of anyone’s skill set, and it slows everything down. This tool can streamline that process and make sure everything’s where it needs to be, that’s a big win.
VP QA
We looked into other electronic QMS software, but they charge $20,000 just to write 10 SOPs, and then they charge an extra $10,000 per year just for hosting version control. It just doesn’t make sense for startups.
R&D Director
My biggest challenge with automation tools is that I don’t see anyone using them to their full potential. I have to move into automation, but it requires a lot of cross-organizational talking, and we don’t have the time to learn.
BD Executive
No one wants to be just filtering through documentation for hours at a time. It’s not the best use of anyone’s skill set, and it slows everything down. This tool can streamline that process and make sure everything’s where it needs to be, that’s a big win.
VP QA
We looked into other electronic QMS software, but they charge $20,000 just to write 10 SOPs, and then they charge an extra $10,000 per year just for hosting version control. It just doesn’t make sense for startups.
R&D Director
My biggest challenge with automation tools is that I don’t see anyone using them to their full potential. I have to move into automation, but it requires a lot of cross-organizational talking, and we don’t have the time to learn.
BD Executive
No one wants to be just filtering through documentation for hours at a time. It’s not the best use of anyone’s skill set, and it slows everything down. This tool can streamline that process and make sure everything’s where it needs to be, that’s a big win.
VP QA
We looked into other electronic QMS software, but they charge $20,000 just to write 10 SOPs, and then they charge an extra $10,000 per year just for hosting version control. It just doesn’t make sense for startups.
R&D Director
My biggest challenge with automation tools is that I don’t see anyone using them to their full potential. I have to move into automation, but it requires a lot of cross-organizational talking, and we don’t have the time to learn.
BD Executive
No one wants to be just filtering through documentation for hours at a time. It’s not the best use of anyone’s skill set, and it slows everything down. This tool can streamline that process and make sure everything’s where it needs to be, that’s a big win.
VP QA
We looked into other electronic QMS software, but they charge $20,000 just to write 10 SOPs, and then they charge an extra $10,000 per year just for hosting version control. It just doesn’t make sense for startups.
R&D Director
My biggest challenge with automation tools is that I don’t see anyone using them to their full potential. I have to move into automation, but it requires a lot of cross-organizational talking, and we don’t have the time to learn.
BD Executive
No one wants to be just filtering through documentation for hours at a time. It’s not the best use of anyone’s skill set, and it slows everything down. This tool can streamline that process and make sure everything’s where it needs to be, that’s a big win.
VP QA
We looked into other electronic QMS software, but they charge $20,000 just to write 10 SOPs, and then they charge an extra $10,000 per year just for hosting version control. It just doesn’t make sense for startups.
R&D Director
My biggest challenge with automation tools is that I don’t see anyone using them to their full potential. I have to move into automation, but it requires a lot of cross-organizational talking, and we don’t have the time to learn.
BD Executive
No one wants to be just filtering through documentation for hours at a time. It’s not the best use of anyone’s skill set, and it slows everything down. This tool can streamline that process and make sure everything’s where it needs to be, that’s a big win.
VP QA
We looked into other electronic QMS software, but they charge $20,000 just to write 10 SOPs, and then they charge an extra $10,000 per year just for hosting version control. It just doesn’t make sense for startups.
R&D Director
My biggest challenge with automation tools is that I don’t see anyone using them to their full potential. I have to move into automation, but it requires a lot of cross-organizational talking, and we don’t have the time to learn.
BD Executive
No one wants to be just filtering through documentation for hours at a time. It’s not the best use of anyone’s skill set, and it slows everything down. This tool can streamline that process and make sure everything’s where it needs to be, that’s a big win.
VP QA
We looked into other electronic QMS software, but they charge $20,000 just to write 10 SOPs, and then they charge an extra $10,000 per year just for hosting version control. It just doesn’t make sense for startups.
R&D Director
My biggest challenge with automation tools is that I don’t see anyone using them to their full potential. I have to move into automation, but it requires a lot of cross-organizational talking, and we don’t have the time to learn.
BD Executive
No one wants to be just filtering through documentation for hours at a time. It’s not the best use of anyone’s skill set, and it slows everything down. This tool can streamline that process and make sure everything’s where it needs to be, that’s a big win.
VP QA
We looked into other electronic QMS software, but they charge $20,000 just to write 10 SOPs, and then they charge an extra $10,000 per year just for hosting version control. It just doesn’t make sense for startups.
R&D Director
My biggest challenge with automation tools is that I don’t see anyone using them to their full potential. I have to move into automation, but it requires a lot of cross-organizational talking, and we don’t have the time to learn.
BD Executive
No one wants to be just filtering through documentation for hours at a time. It’s not the best use of anyone’s skill set, and it slows everything down. This tool can streamline that process and make sure everything’s where it needs to be, that’s a big win.
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.