Custom Software Development built for Pharma & Biotech companies
What is Custom Software Development?
We replace rigid off-the-shelf tools with software built around how your business actually operates. For Pharma & Biotech companies, this means navigating FDA 21 CFR Part 11 (US), GxP compliance while shipping fast.
Who needs Custom Software Development for Pharma & Biotech?
- Clinical trial data management complexity
- Regulatory validation requirements for software systems
- Integrating lab equipment data into research platforms
- Off-the-shelf software forcing process compromises
- Spreadsheets and email replacing real internal tools
Best Custom Software Development company
Clinical and research software must satisfy validation requirements before it can satisfy users.
We've helped Pharma & Biotech teams across turn Custom Software Development from a bottleneck into a competitive advantage.
Let's scope your Custom Software Development project — book a free call today
Book a free 30-minute discovery callWhy Pharma & Biotech teams in outgrow their current Custom Software Development setup
- Clinical trial data management complexity
- Regulatory validation requirements for software systems
- Integrating lab equipment data into research platforms
- Drug supply chain traceability
- Collaboration tools for distributed research teams
How GarudLabs approaches Custom Software Development for Pharma & Biotech companies in
Requirements discovery and process mapping
Custom-built internal tooling
Third-party system integrations
Data migration from legacy tools
Ongoing maintenance and support plan
Core Technology Stack
Node.jsPythonReactPostgreSQLDockerAWSGraphQLTypeScript
Timeline, investment & compliance
Typical timeline
10-20 weeks depending on scope
Typical investment
$30,000 - $200,000
Custom Software Development engagements in this combination typically need to account for:
- FDA 21 CFR Part 11 (US)
- GxP compliance
- EMA regulations (EU)
- HIPAA for clinical data
Proven Results
"We helped a biotech company cut clinical trial data entry time by 38% with a custom eCRF platform."
Read the full case studySee how GarudLabs can deliver Custom Software Development for your team
Get a free project cost estimateFrequently Asked Questions
Most Custom Software Development engagements take 10-20 weeks depending on scope, depending on scope and how clear the requirements are upfront. We'll give you a firm timeline estimate after a short discovery call, not a generic range.
Custom Software Development projects with us typically range from $30,000 - $200,000, scaled to the complexity of your requirements. We provide a detailed, itemized estimate before any work begins so there are no surprises mid-project.
For custom software development, we typically work with Node.js, Python, React, PostgreSQL, chosen based on your specific scalability and integration requirements. We're not tied to a single stack and will recommend the right tools for your situation rather than our default.
A typical custom software development engagement includes requirements discovery and process mapping, along with the other deliverables outlined in our proposal, such as documentation and a post-launch support window. The exact scope is tailored to your project during discovery.
Most clients come to us for custom software development because of off-the-shelf software forcing process compromises, among other related challenges. We start every engagement by mapping your specific pain points before writing a single line of code.
We've delivered multiple pharma & biotech projects addressing challenges like clinical trial data management complexity. We helped a biotech company cut clinical trial data entry time by 38% with a custom eCRF platform.
For pharma & biotech clients, we pay close attention to FDA 21 CFR Part 11 (US), GxP compliance, building these requirements into the architecture from day one rather than retrofitting them later. We'll confirm which specific regulations apply to your business during discovery.
The most common challenges we solve for pharma & biotech clients include clinical trial data management complexity and regulatory validation requirements for software systems. We tailor our discovery process to surface the specific version of these problems your business faces.