Appsilon GxP Audit
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.
Increase chances of smooth FDA submission process
Software validation is an important element of success in submitting to regulatory bodies. We will help you improve development workflows, implement secure software practices, conduct unit and performance tests, and ensure proper documentation.
Average cost of developing a new drug.
Avoid wasting billions due to failed submissions caused by non-compliance.
Average time for drug development.
Prevent delays by meeting regulatory requirements from the start.
50% Reporting Time
Saved
Cut time spent on manual reporting tasks in half, enabling teams to focus on high-value work based on demonstrated results.
$1M+ Operational Costs Reduced
Reduce expenses over three years through automated compliance and operational efficiency driven by proven methods.
100% Data Quality Ensured
Eliminate manual errors and enhance data accuracy throughout your processes with results rooted in practical experience.
GxP Audit for Clinical Programming Teams
Get a detailed evaluation of workflows and compliance gaps, with actionable recommendations delivered to meet GxP standards.
Book The Audit20
Audit Areas
Covering good development, security, validation, and reproducibility
4-6
Week Timeline
Delivering results efficiently within a streamlined process.
1
Insights Report
Highlighting risks, compliance gaps, and key areas for improvement
1
Clear Action Plan
Providing step-by-step guidance to achieve GxP compliance.
Team
Training
Targeted support to equip your staff with knowledge to implement best practices effectively.
Appsilon: Innovation for Impact
Appsilon empowers pharmaceutical and life sciences companies to leverage open-source technology for faster, data-driven decision-making in regulated environments.
1% Top Talent
Only 1% of applicants pass our rigorous selection process, ensuring top-tier engineers.
275K+ Open Source Downloads
Our packages are actively shaping the ecosystem with significant contributions from our engineers.
100+ Talks and 7 Papers
With 5 PhDs on the team, we share insights through conferences and published research.
82% Adoption Rate
The majority of our applications are integrated into key business operations, driving success for our clients.
How It Feels to Work With Us
Director, at Top 5 Pharma Company
Basel, Switzerland
Director
at Top10 Pharma Company
Director, at Top 5 Pharma Company
Basel, Switzerland
100% GxP-Compliant Software Development
See how clients improved compliance, simplified workflows, and worked more effectively with our solutions.
Navigate GxP Compliance with Expert Help
FAQs About GxP
Find clear answers to common questions about GxP compliance, helping you navigate regulations with confidence.
What type of follow-up support is available after the GxP audit?
Appsilon provides ongoing support to ensure the successful implementation of audit findings. Our services include implementing recommendations from the audit, building Statistical Computing Environments (SCE), developing dashboards, and leveraging AI to support drug discovery and compliance efforts. Whatever your needs are, we are here to assist with tailored solutions.
Are your experts available to implement the audit recommendations?
Yes, our team is available to assist with implementing recommendations and optimizing your processes as needed.
How can your services assist with FDA/EMA submissions?
Our services help with FDA/EMA submissions by setting up GxP-compliant environments, preparing documentation for audits and ensuring data accuracy through testing to improve development processes.
What other services and support do you offer around GxP validation?
We also offer services such as GxP best practices, performing risk assessments, validating custom software tools, and providing ongoing support to maintain compliance. We can also help with dashboards, platform management, Statistical Computing Environments (SCE), DataOps, cloud infrastructure, and using AI to improve processes.
What kind of experts are assigned to the audit?
Our audit team includes senior-level architects to review code and workflows, platform engineers to evaluate infrastructure, and project managers to compile comprehensive reports based on industry standards.
How quickly can we start working together?
We can begin working together 4 weeks after signing the agreement. This allows us time to prepare a team and ensure a smooth onboarding process into your systems.
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Ready to Tackle Challenges with GxP?
We’re here to help! Share your project with us, and let’s discuss how we can make sure your software meets regulatory requirements.