Cross-industry engineering experience across regulated and high-growth sectors.
All Industries
“A pharma company used custom advanced analytics to reduce deviations by more than 65 percent.” — McKinsey & Company
We extend LIMS and ELN functionality and keep sample data traceable to the report.
Study management, electronic data capture, and integrations between the trial systems you run.
Experiment, assay, and compound data from many sources brought into one searchable place.
Safety case intake and review workflows connected to the safety database you already run.
Document control, CAPA, deviations, training, and quality events built as configurable workflows.
Production records and electronic batch records connected to your quality and ERP systems.
ERP, inventory, and distribution systems connected to your quality and manufacturing software.
CRM and HCP portals for commercial teams, plus apps that reach clinicians and patients.
Our engineers brought release automation, workflow validation, and audit-ready reporting to the Validation on Demand project.
“Despite these investments, only 22% of life sciences leaders said they have successfully scaled AI, and just 9% reported achieving significant returns on these efforts.” — Deloitte
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A pharmaceutical software development company builds and maintains the software pharma, biotech, and life sciences teams run regulated work on, such as lab, clinical, quality, and manufacturing systems. At Zoolatech, the same team writes the code, the tests, and the validation evidence your quality unit reviews, as in our work on MasterControl’s quality and manufacturing software.
It depends on what the software does: 21 CFR Part 11 covers electronic records under any FDA records requirement, and GAMP 5 is ISPE’s industry guide rather than a regulation. FDA’s CSA guidance and the QMSR are scoped to medical device manufacturers.
We trace each requirement from your regulations and SOPs to its tests and results and build audit trails, electronic signatures, and access controls into the code. FDA’s guidance on electronic records in clinical investigations keeps regulated entities responsible for meeting Part 11, and an article in ISPE’s Pharmaceutical Engineering places accountability for GxP requirements with the regulated company, so the final call stays with your quality unit.
It depends on what changed and the risk to product quality and data, and your quality team sets the scope. FDA’s risk-based approach for device manufacturers is explained in our guide to computer software assurance.
Ask for named regulated-product work, who writes the tests and validation documentation, how changes are controlled, and who can access your data.
Buy when a platform covers your process as it runs today, because you can use its vendor documentation in your own validation where it applies. Build or extend when your workflows, integrations, or data fall outside it.
Scope drives both: the number of systems and integrations, how much legacy data has to move, the regulatory controls required, and the validation evidence you expect. These differ by project, so cost and timeline are estimated once the scope is clear.
Two common models can be combined: with team extension, our engineers join your product teams and work in your process. With managed delivery, we run a product or work stream end to end while you set priorities and accept each release.
