LIMSCTMSPharmacovigilance21 CFR Part 11GxP

Pharmaceutical Software Development — LIMS, CTMS & Regulatory Apps

Custom pharma software built to GxP standards — LIMS, clinical trial management, pharmacovigilance, and regulatory compliance — at 65% below US rates.

Pharma Software Services

Validated, compliant software for the life sciences industry

LIMS (Lab Information Management)

Sample tracking, test result management, instrument integration, CoA generation, audit trails, 21 CFR Part 11 electronic signatures.

from $3,500/mo

CTMS (Clinical Trial Management)

Site management, patient enrollment tracking, protocol deviation logging, investigator portals, regulatory document management (eTMF).

from $4,000/mo

Pharmacovigilance

Adverse event intake and case processing, ICSR submissions (E2B R3), aggregate safety reporting (PSUR/PBRER), signal detection dashboards.

from $3,500/mo

Regulatory Submissions

eCTD authoring support tools, dossier compilation workflows, FDA/EMA module management, submission tracking and status portals.

from $3,000/mo

Drug Discovery & Bioinformatics

Compound data management, HTS data pipelines, molecular data visualization, ELN integrations, biomarker analysis dashboards.

from $4,000/mo

Supply Chain & Serialization

Track-and-trace for DSCSA compliance, serialization systems, temperature/cold chain monitoring, batch recall management.

from $3,000/mo

Why CodeMiners for Pharma?

GxP-Aware Development

21 CFR Part 11, Annex 11, GMP, GCP, GLP — our developers understand validation requirements and build audit trails into every system.

Validation Documentation

We provide IQ/OQ/PQ documentation, risk-based testing strategies (GAMP 5), and traceability matrices as part of delivery.

Data Integrity by Design

ALCOA+ principles embedded from requirements — attributable, legible, contemporaneous, original, accurate audit logs built into every module.

Build Your Pharma Software Today

GxP-compliant pharma software from $3,000/month. Start in 48 hours.

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