Life Sciences Software
Development & Solutions

We develop software that fully complies with global life sciences regulations, such as FDA 21 CFR Part 11 for electronic records and signatures, GxP guidelines like GCP, GLP, and GMP, HIPAA for patient data privacy, and GDPR for data protection.

Yes. Our development lifecycle includes complete validation packages that cover IQ (Installation Qualification), OQ (Operational Qualification), and PQ (Performance Qualification) to ensure your software is fully prepared for audits.

Absolutely. We build custom data pipelines and APIs to connect with LIMS (Laboratory Information Management Systems), EDC (Electronic Data Capture), ERP systems, and IoT-enabled manufacturing devices.

We enforce strict data protection strategies such as end-to-end encryption with AES-256 for stored data and TLS 1.3 for data in transit, secure multi-factor authentication (MFA), and role-based access controls (RBAC) to meet with HIPAA, GDPR, and HITRUST standards.

The timelines for life sciences software development are generally longer than standard commercial software due to the need for rigorous regulatory validation. Approximately 20% to 30% of the overall timeline is dedicated purely to rigorous QA, penetration testing, and formal IQ/OQ/PQ validation to ensure the software is audit-ready.

• Minimum Viable Product (MVP) / Pilot Platform: 3 to 6 months
• Core Enterprise Solution (e.g., Clinical Trial Management, RWE Platform): 6 to 12 months
• Complex Ecosystems (e.g., AI-driven drug discovery or global manufacturing IoT): 12 to 18+ months

The cost varies heavily depending on software complexity, integration requirements, and regulatory risk classification (such as SaMD Class I, II, or III).

Small-Scale / MVP$75,000 – $150,000 — Ideal for basic internal data pipelines, standalone BI dashboards, or early-stage research prototypes.

Mid-Tier Enterprise Solutions$150,000 – $400,000 — Ideal for automated patient recruitment platforms, specialized RWE data platforms, or compliant GxP workflow automation.

Large-Scale / Flagship Ecosystems$400,000 – $1,000,000+ — Ideal for global pharmaceutical supply chain IoT platforms, multimodal AI/ML discovery engines, or fully certified Software as a Medical Device (SaMD).

The cost premium is due to specific requirements unique to the healthcare and pharmaceutical sectors:

• Regulatory Compliance & Validation: Engineers must create comprehensive traceability matrices and validation protocols (IQ/OQ/PQ) when building under FDA 21 CFR Part 11 and GxP guidelines
• Advanced Data Security: Adhering to HIPAA/GDPR compliance standards, using multi-layer encryption, and enforcing strict role-based access control (RBAC) requires specialized expertise in cybersecurity engineering
• Complex Data Integration: Integrating different healthcare systems such as EHRs, LIMS, and EDC demands development of custom APIs and knowledge of data standards like FHIR and HL7

AI and ML are deeply transforming the life science industry in several areas:

• Clinical Trials: Matching patients to trials using NLP on electronic health records
• Drug Discovery: Applying predictive analytics to molecular structures using frameworks like PyTorch or TensorFlow
• Supply Chain: Leveraging predictive demand forecasting to check medication shortages
• Real-World Evidence (RWE): Combining large volumes of unstructured patient data into useful clinical insights