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.

astellas
Genmab
merck
johnson and johnson
World Health Organisation
Kenvue
Phuse
Pharmaverse
astellas
Genmab
merck
johnson and johnson
World Health Organisation
Kenvue
Phuse
Pharmaverse
Code You Can Trust

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.

$1-2 Billion

Average cost of developing a new drug.

Avoid wasting billions due to failed submissions caused by non-compliance.

10-12 Years

Average time for drug development.

Prevent delays by meeting regulatory requirements from the start.

Leding Research-Focused Biopharmaceutical Company

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.

How to Start?

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 Audit

20

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.

Our Expertise

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.

Our Clients About Appsilon

How It Feels to Work With Us

"The team is absolute gem. Proactive and bringing in fresh ideas on a technical and workflow level."

Director, at Top 5 Pharma Company

Basel, Switzerland

"Delivery - excellent, proactive, focused on value. It’s about understanding business contexts, coming up with ideas. I’m super pleased."

Director

at Top10 Pharma Company

"Appsilon really helped us accelerate. Quality is great, accountability, speed."

Director, at Top 5 Pharma Company

Basel, Switzerland

Let’s Solve It Together

Navigate GxP Compliance with Expert Help

Appsilon Experts
Book a call with our GxP experts to address your compliance challenges.
We will contact you within 24 hours!
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FAQs About GxP

Find clear answers to common questions about GxP compliance, helping you navigate regulations with confidence.

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.

Yes, our team is available to assist with implementing recommendations and optimizing your processes as needed.

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.

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.

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.

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.

Let's Talk

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.

Talk to our Experts