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Pharma & Biotech

Pharma & Biotech Software Development Company

FISTA Solutions builds software for pharma and biotech under GxP expectations: clinical trial operations tooling, laboratory and quality system integrations, pharmacovigilance workflows, manufacturing and supply visibility, and AI agents for regulated document work with validation evidence built in.

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150+
projects delivered
50+
companies served
99.9%
verified uptime
47%
efficiency gains
12+
countries reached

What we build

What does a pharma and biotech software development company build?

FISTA builds clinical operations dashboards and trial tooling, lab and quality system integrations, pharmacovigilance intake and triage, manufacturing and supply visibility, regulatory document pipelines, and AI agents that draft and extract inside a validated, fully audited envelope.

  1. 01

    Clinical operations tooling

    Study startup trackers, site performance dashboards, enrollment forecasting, and monitoring workflows across EDC and CTMS data.

    Clinical
  2. 02

    Lab and quality integration

    LIMS, ELN, and QMS integrations that replace spreadsheet handoffs with validated, traceable data movement.

    Lab & QA
  3. 03

    Pharmacovigilance workflows

    Case intake from multiple channels, duplicate detection, triage, and narrative preparation supporting regulatory timelines.

    Safety
  4. 04

    Manufacturing and supply visibility

    Batch, deviation, and supply dashboards over MES and ERP data so quality and operations see the same numbers.

    CMC
  5. 05

    Regulatory document pipelines

    Structured authoring support, document assembly, and submission-ready outputs with version control and signature capture.

    Regulatory
  6. 06

    Life sciences AI agents

    Protocol and literature summarization, safety narrative drafting, and document extraction — all traceable, reviewed, and validated for intended use.

    AI

Requirements

Which requirements shape pharma and biotech software development?

Life sciences software must be validated for its intended use, keep records that regulators can trust, and never lose the thread between data and decision. That means Part 11 controls, ALCOA+ data integrity, documented validation, and change control that survives inspection.

Pharma & Biotech: requirements and how FISTA Solutions builds to them
RequirementWhat it means hereHow FISTA builds to it
21 CFR Part 11Electronic records and signatures need controls, audit trails, and identity assurance.Unique identity and signature meaning capture, tamper-evident audit trails, retention controls, and system access documentation.
Computer system validationGxP systems require documented evidence that they do what they are specified to do.URS, functional and design specs, IQ/OQ/PQ protocols, traceability matrix, and executed evidence delivered with the release.
Data integrity (ALCOA+)Data must be attributable, legible, contemporaneous, original, and accurate.Append-only event capture, timestamp discipline, no silent edits, and reason-for-change prompts on every correction.
Subject privacyTrial and safety data include identifiable personal and health information.Pseudonymization, region-pinned storage, role-based access, and de-identified datasets for analytics and development.
Change controlChanges to validated systems require assessment and documentation.Risk-assessed change process, regression evidence per release, and validation impact documented before deployment.

Where AI fits

Where do AI agents fit in pharma & biotech?

AI agents fit life sciences where text volume is high and review is mandatory: protocol and literature summarization, safety narrative drafting, deviation triage support, regulatory document assembly, and site communication. Every output is traceable to source, reviewed by qualified staff, and validated for its intended use.

  1. 01

    Literature and protocol summarizer

    Produces structured summaries with citations to the exact source passage, speeding review without replacing it.

  2. 02

    Safety narrative drafter

    Drafts case narratives from structured safety data for qualified reviewer editing, with every field traceable to its source record.

  3. 03

    Deviation triage support

    Classifies deviations, retrieves similar historical cases, and proposes the investigation path for quality review.

  4. 04

    Document assembly agent

    Assembles submission and report sections from approved content with version and approval status visible throughout.

  5. 05

    Site query agent

    Drafts responses to routine site questions from approved study documents, escalating anything protocol-affecting to study staff.

Cost and timeline

How much does pharma and biotech software development cost, and how long does it take?

Cost is driven by validation depth, the number of regulated systems integrated, and data migration; timeline by quality review and validation execution rather than by coding. FISTA does not quote blind: the scoping call returns a specification, a validation plan, and an estimate.

In GxP environments, validation is a substantial and predictable share of the budget. FISTA scopes it explicitly — specifications, protocols, execution, and traceability — instead of hiding it inside an engineering estimate, so your quality group can review the plan before the build begins.

Risk-based scoping keeps that cost proportionate. Not every module carries the same GxP impact: an internal analytics dashboard and a system generating records for submission deserve different rigor. FISTA classifies components by impact in discovery, so validation effort lands where regulators actually expect it.

Send the scope you have, even if it is a paragraph. You get a written brief, an architecture sketch, and a phased estimate before any commitment.

Get a scoped quote

Delivery

How does FISTA deliver an industry software project?

FISTA delivers in four gated phases: a discovery sprint that produces the specification and integration map, an architecture and compliance design that names every control, iterative builds demoed weekly on your environment, and a verified release with runbooks, monitoring, and a handover or a managed operations option.

  1. 1

    Discover and specify

    Stakeholder interviews, system inventory, data classification, and a written specification with acceptance criteria and a phased plan.

    Output

    Specification, integration map, estimate

  2. 2

    Design for compliance

    Architecture, data model, security controls, and the evidence plan for any audit, agreed before the first sprint.

    Output

    Architecture decision record, control matrix

  3. 3

    Build and demonstrate

    Two-week sprints with automated tests, contract tests on integrations, and a demo on your environment every week.

    Output

    Working increments in your repository

  4. 4

    Verify and operate

    Load, security, and acceptance testing against the spec; release with runbooks, dashboards, and alerting; optional managed operations.

    Output

    Verified release, runbooks, SLOs

Why FISTA

Why choose FISTA Solutions for pharma and biotech software development?

FISTA builds life sciences software with validation as a deliverable, not a phase bolted on at the end, and applies AI only where output is traceable and reviewed. Engagements are contracted through a US entity, and every release ships with the evidence your quality organization needs.

Pharma & Biotech specifics

  • Validation artifacts — URS, specifications, protocols, traceability — are produced with the build, not reconstructed afterwards.
  • Risk-based classification so GxP rigor is applied where impact justifies it, keeping cost proportionate.
  • AI outputs are traceable to source passages and reviewed by qualified staff before use in any regulated process.
  • Audit trails are tamper-evident and reason-for-change is captured, supporting ALCOA+ expectations.

How FISTA engineers

  • Spec-Driven Development: every deliverable starts as a written specification with acceptance criteria, so scope is testable before it is built.
  • AI-native delivery: engineers direct coding agents under review gates and evaluation harnesses, compressing build time without loosening verification.
  • Official Anthropic partner, with production experience across Claude, OpenAI, Google, and open-weight models, chosen per workload rather than by default.
  • One accountable delivery lead, weekly demos on your environment, and code in your repositories from week one.

What you get as a client

  • 150+ projects delivered for 50+ companies across 12+ countries since 2017, with 99.9% verified uptime on systems we operate.
  • A US entity (FISTA Solutions Inc., Wilmington, Delaware) for contracting, invoicing, and IP assignment, with an engineering center in Faisalabad, Pakistan for cost-efficient senior capacity.
  • US business-hours overlap for standups and reviews; written decision logs so nothing depends on a meeting you missed.
  • Flexible engagement: fixed-scope build, embedded forward deployed engineers, or a dedicated team that you can scale month to month.

Clear answers

What buyers in this industry ask first.

Straightforward guidance for evaluating scope, fit, and the next step.

01Can FISTA deliver 21 CFR Part 11 compliant systems?

FISTA builds the technical controls Part 11 requires — unique identity, signature meaning, tamper-evident audit trails, retention, and access control — and delivers the validation documentation. Compliance also depends on your procedures and training, so the controls and evidence are documented for your quality organization.

02Do you provide computer system validation documentation?

Yes. User requirements, functional and design specifications, IQ/OQ/PQ protocols, a traceability matrix, and executed evidence are produced as part of delivery, with the rigor scaled to each component's GxP impact.

03Is generative AI acceptable in a GxP process?

Where the output is traceable, reviewed, and the system is validated for its intended use. FISTA applies AI to drafting and summarization with citations and qualified human review, and documents the intended use, limitations, and evaluation evidence.

04Can you integrate with our EDC, CTMS, or LIMS?

Yes, through their supported APIs and export interfaces, with validated data movement, reconciliation checks, and CDISC-aligned structures where downstream submission work depends on them.

05How do you protect subject data?

Pseudonymization by default, region-pinned storage, strict role-based access, and de-identified datasets in development and analytics environments, with data flows documented for your privacy assessments.

06How long does a validated build take?

Longer than an equivalent non-regulated system, because validation execution and quality review are real calendar items. The discovery sprint produces a plan that names those gates and their owners, so the date reflects your organization's process.

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Related capabilities

Healthcare software developmentClinical systems, EHR integration, and HIPAA-aligned patient platforms.Document AI developmentExtraction and classification pipelines with measured accuracy and provenance.AI in clinical trialsField note on where AI speeds trial operations without risking data integrity.

Scoped in writing before you commit

Build regulated software with the evidence already in hand.

Bring the process, the systems, and your quality requirements. The scoping call returns a specification, a risk-based validation plan, and a phased estimate.

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