Custom SaaS Development in Basel
Healthcare and life sciences SaaS platforms built for regulatory compliance and innovation
Custom SaaS Development in Basel
As the global center for pharmaceutical and life sciences innovation, Basel requires SaaS platforms that meet the highest standards of security, compliance, and reliability. AETHER Digital specializes in building healthcare and biotech SaaS applications that handle sensitive patient data, support clinical research, and streamline complex workflows.
Our team understands the unique challenges of healthcare software: GDPR and HIPAA compliance, electronic health record (EHR) integrations, clinical trial management, patient data security, and regulatory validation. We've built platforms for pharmaceutical research, medical device monitoring, laboratory information management systems (LIMS), and patient engagement portals.
Serving Basel's renowned pharmaceutical companies, biotech startups, and research institutions, we deliver SaaS solutions that accelerate innovation while maintaining strict regulatory compliance. From drug development tracking to clinical trial recruitment, from telemedicine platforms to laboratory automation—we build software that saves lives.
Every platform includes comprehensive audit trails, role-based access controls, data encryption, secure API integrations with clinical systems, and documentation meeting GxP and FDA validation requirements.
Pharmaceutical giants (Roche, Novartis), life sciences, chemical industry, banking
- ✓Pharmaceutical companies in Basel
- ✓Biotech and life sciences startups
- ✓Clinical research organizations (CROs)
- ✓Medical device manufacturers
- ✓Healthcare providers and hospitals
- ✓Laboratory and diagnostic companies
- ✓Digital health innovators
Benefits for Basel Businesses
GDPR, HIPAA, and Swiss data protection compliance built-in
GxP-validated development processes for pharmaceutical applications
HL7/FHIR integrations with electronic health records
Comprehensive audit trails and regulatory documentation
Role-based access control for clinical and research teams
Secure patient data handling with encryption at rest and in transit
Clinical trial management and patient recruitment tools
Laboratory information management system (LIMS) capabilities
Our Process
Regulatory Requirements Analysis
Identify all regulatory requirements (GDPR, HIPAA, FDA 21 CFR Part 11, GxP), compliance needs, data handling requirements, and validation documentation needed for your healthcare SaaS platform.
Secure Architecture Design
Design HIPAA-compliant architecture with encryption, secure authentication, audit logging, and data isolation. Plan integrations with EHR systems, lab equipment, and clinical databases.
Validated Development Process
Build application following validated software development lifecycle (SDLC) with requirements traceability, design specifications, and comprehensive testing documentation.
Security & Compliance Testing
Conduct penetration testing, vulnerability assessments, HIPAA compliance audits, and regulatory validation. Create validation documentation for FDA or Swissmedic submissions if required.
Deployment & Validation Support
Deploy to compliant infrastructure (Swiss data centers or certified cloud), provide validation support documentation, and establish monitoring for regulatory compliance.
What You Receive
Frequently Asked Questions
Do you have experience with FDA-regulated software?
Yes, we follow FDA guidelines for software as a medical device (SaMD) and have experience with 21 CFR Part 11 compliance, validation documentation, and quality system regulations (QSR). We can support FDA or Swissmedic submissions.
Can you integrate with existing hospital EHR systems?
Absolutely. We have extensive experience integrating with major EHR systems using HL7 v2, HL7 FHIR, and proprietary APIs. Common integrations include Epic, Cerner, Allscripts, and European systems like iMedOne and HYDMedia.
How do you ensure HIPAA compliance?
We implement comprehensive security controls including encryption (AES-256), secure authentication (MFA), audit logging, access controls, and secure data transmission (TLS 1.3). We use HIPAA-compliant hosting providers and can provide BAA agreements.
Can you host healthcare data exclusively in Switzerland?
Yes, we work with Swiss data center providers to ensure all patient data remains within Switzerland, meeting the strictest data sovereignty requirements. We can also implement hybrid architectures with data residency controls.
What about GxP validation for pharmaceutical applications?
We follow GAMP 5 guidelines for software validation in regulated industries. This includes validation planning, requirements traceability matrices, design specifications, test protocols, and validation summary reports.
How long does the validation process take?
Validation adds 2-4 months to the development timeline depending on risk classification. Higher-risk medical devices or pharmaceutical systems require more extensive validation documentation and testing.
Do you provide ongoing compliance support?
Yes, we offer compliance maintenance contracts including security updates, audit support, validation of changes, and regulatory documentation updates as requirements evolve.
Ready to Get Started? in Basel?
Let us help your Basel business dominate the digital landscape. Contact us today for a free consultation.