GxP Compliance
Regulatory Compliance for R- and Python-based Scientific Computing Environments
Our engineers create and deploy customized computing environments to ensure full regulatory compliance.
Boost Confidence in Your Clinical Programming and Data Science Teams
Focus on advancing drug development while we ensure your data workflows and technology stack meet the required GxP regulations.
Regulatory Compliance
We guarantee high-quality code and strong security, so your systems run smoothly and meet regulations.
Fast Implementation
Our ready-to-use tools speed up development, saving you time and keeping your company competitive in the pharma market.
Scientific Innovation
With biotech and software programming expertise, we address your unique challenges, helping you drive innovation in clinical development.
Scalable and Custom Solutions
You can start with an audit or development support, and scale up as your needs grow, giving you full flexibility over the scope.
GxP Reporting Automation: From 5 Weeks to 5 Minutes
Reducing the time needed to generate Annual Product Quality Review (APQR) by 85% for a premier biopharmaceutical company's GxP compliance process.
50%
Reduction in manual reporting, allowing teams to focus on high-value tasks.
85%
Automation of GxP reports, improving accuracy and compliance.
Guiding You Through GxP Compliance
We help companies navigate the complexities of regulatory compliance, ensuring fast adoption of technology and meeting regulations efficiently.
Data Engineering Lead
at a top10 Pharma Company
GxP Compliance Audit for Clinical Data Science
Conduct a comprehensive analysis of your R- or Python-based scientific computing environment and receive a detailed report with actionable recommendations and areas for improvement.
Data Visualization Dashboards
Develop dashboards and applications that provide real-time insights, helping your clinical teams make informed decisions faster. From prototyping to large-scale decision support systems, we can help you leverage your data with ease.
Scientific Computing Environments
Build working environments for clinical data science and analysis, ensuring GxP compliance, security, and reproducibility.
Cloud Infrastructure
Design, deploy, and optimize your cloud infrastructure to increase ROI, securely share data, and improve compliance.
Your GxP Compliance Partner
With over a decade of experience and world-class engineers, we bridge the gap between software development and successful drug development.
World-Class Engineering Talent
Our team consists of the top 1% of software engineers globally, bringing unmatched expertise in developing GxP-software and infrastructure for life sciences and pharma.
Partners to 7 out of Top 10 Pharma Companies
We’ve successfully delivered hundreds of projects for top biotech and pharma companies, providing the technical foundation for clinical trials and drug development.
Dedicated DoD and AQT Processes
Our proprietary Definitions of Done (DoD) and Appsilon Quality Test (AQT) processes ensure that your software and computing environment meets the highest standards of GxP compliance.
Leveraging the Best Technologies
We combine reliable and tested technology with scientific expertise to deliver high-quality, compliant solutions. Here’s a glimpse of the tools we work with.
Is Your Software GxP Compliant?
Download a checklist designed for clinical managers in data departments to make sure that software meets requirements for FDA and EMA submissions.
Get the ChecklistHelping Pharma Teams Like Yours Achieve GxP Compliance
Sarah Gasman, Senior Data Analyst
Boston Medical Center
Data Engineering Lead
at a top 10 Pharma Company
Human Resources People Partner
at a top 10 Pharma Company
Driving Regulatory Compliance for Leading Pharmaceutical CompaniesCaption
Our solutions are designed to meet your GxP compliance needs, ensuring your company stays audit-ready and efficient.
Get Custom Regulatory Compliance Support
Stay Informed with GxP Compliance Tips and Trends
FDA Compliance in Software Development: Cases Where Poor Software Quality Led to Costly FDA Rejections
Ensure Your R and Python Code
Meets FDA and EMA Standards
A comprehensive diagnosis of your R and Python software and computing environment compliance
with actionable recommendations and areas for improvement.
FAQs
We understand GxP compliance can be complex, so we’ve gathered answers to some of the most common questions to help you navigate the process and better understand the requirements.
What is GxP Compliance?
GxP compliance ensures that software and processes in regulated industries, like pharmaceuticals, meet specific guidelines for quality and safety. Compliance means adhering to these GxP standards throughout the software development lifecycle.
Why is GxP Compliance Important?
GxP compliance is crucial because it ensures that the products and processes used in life sciences are safe, effective, and meet regulatory standards. Compliance reduces risks of failures, delays, and potential legal issues during regulatory submissions.
What is GxP in Software Development (GSEP)?
GxP in software development refers to ensuring that the software used in regulated industries meets Good Practices (GxP) guidelines. GSEP (GxP Software Engineering Practices) ensures that the software is reliable, traceable, and compliant.
What are the Best Technologies for GxP Compliance?
The best technologies for GxP validation include R, Python, Git for version control, automated testing tools, and cloud platforms like AWS or Azure. These tools ensure proper documentation, traceability, and regulatory compliance in software development
What Does the FDA Submission Process Look Like?
The FDA submission process involves preparing detailed documentation of the product’s development, testing, and validation. It includes reports on compliance with GxP standards and evidence that the product meets safety and efficacy requirements.
What Does the EMA Submission Process Look Like?
The EMA submission process requires thorough documentation on clinical trial data, validation of processes, and adherence to GxP standards. The submission focuses on proving that the product is safe and effective for market approval within the EU.
Check our Services
Ready to Tackle Your Challenges?
We’re here to help! Share your project with us, and let’s discuss how we can streamline your GxP compliance needs.