A London software house built inside the pharmaceutical industry.
Codesplice was established by pharmaceutical IT specialists who spent years working within regulated manufacturing and distribution environments before founding the business.
For over 25 years, we have operated exclusively within the pharmaceutical sector. We do not serve other industries. We do not adapt generic platforms. We build pharmaceutical compliance software, and we build nothing else.
SME500 United Kingdom 2026
ISO 9001:2015 (11918-QMS-001)
ISO 27001:2022 (11918-ISMS-001)
Cyber Essentials Certified
G-Cloud 15 Validated Supplier
We exist to make pharmaceutical compliance a solved problem, not an ongoing risk.
Senior pharmaceutical executives should not be spending board time on compliance infrastructure. Their quality directors, responsible persons, and regulatory affairs teams should not be managing paper-based systems or wrestling with generic software that was never designed for their regulatory context.
Codesplice exists to take that burden off the table permanently. Our platforms generate compliance evidence automatically, surface risk proactively, and produce the documentary record that regulators expect, on demand.
When a Codesplice client walks into an MHRA or EMA inspection, compliance documentation is not a concern. That is our standard.
UKAS ISO 9001 & 27001 Certified
Our development quality management system is UKAS ISO 9001 & 27001 certified — demonstrating rigorous controls over client data and system access.
IASME Cyber Essentials
Certified under the UK Government-backed IASME Cyber Essentials scheme, confirming our baseline cyber security posture meets national standards.
GAMP5 Aligned
Our Software Development Lifecycle follows GAMP5 principles, with IQ/OQ documentation supplied as standard with every deployment.
UK & EU Dual Jurisdiction
Deep expertise in both MHRA and EMA regulatory frameworks — essential post-Brexit for organisations operating across both markets.
From contract to compliant operations
Our implementation methodology is refined across multiple pharma deployments. Predictable, low-risk, and designed for organisations where downtime is not an option.
Discovery & Gap Analysis
We assess your compliance posture against applicable GDP and GMP guidelines within 5 business days.
Configuration Sprint
Our implementation team configures your environment against your SOPs and organisational structure.
Validation & UAT
We execute IQ/OQ protocols with your QA team and support user acceptance testing with full documentation.
Go-Live & Support
Dedicated support through your inspection cycles. Regular updates help you stay aligned with evolving regulatory requirements.
Speak with a pharmaceutical compliance specialist.
No obligation. Our team provides strategic compliance guidance regardless of whether you choose to deploy a Codesplice product.