# Pharma Software Development > Custom pharmaceutical software development: clinical trial, quality, lab, manufacturing and regulatory systems. Source: https://authect.com/industries/pharma We design and build software for research, clinical, manufacturing and quality teams, ready for validation, from first prototype to production, with the founders writing the code. ## What you get with Authect's pharma software development Pharmaceutical work runs on **data integrity, traceability and documented process**. Authect builds the software that supports it: clinical and lab systems, quality and document workflows, manufacturing tools and the integrations that tie them together. We work as a **small team led by the founders and senior engineers**, so the people who scope your system are the people who build it. Validation is easier when the software was built to be validated. We design with **audit trails, electronic signatures and role-based access** from the start, keep requirements traceable to tests, and hand you code, infrastructure and documentation you own outright. ## What's included in our pharma software development services - [Application development](https://authect.com/services/application-development): Web and mobile apps for researchers, site staff, quality teams and patients, built around regulated workflows and the records each step has to leave behind. - [Enterprise applications](https://authect.com/services/enterprise-applications): Integration and extension of ERP, CRM, LIMS and quality platforms, so batch, product and customer data flows between systems instead of being re-keyed. - [Data engineering](https://authect.com/services/data-engineering): Pipelines and data platforms that bring together lab, clinical, manufacturing and commercial data with lineage, versioning and controlled access. - [Intelligent document processing](https://authect.com/services/intelligent-document-processing): Extraction and classification of batch records, SOPs, adverse event reports and regulatory documents, with human review before anything enters a controlled record. - [Quality assurance](https://authect.com/services/quality-assurance): Risk-based testing with traceability from requirements to test evidence, structured to support your computer system validation rather than replace it. ## How we help pharmaceutical organisations move faster 1. **Replace paper and spreadsheets**: Digital workflows for deviations, batch review, sample tracking and approvals cut manual handoffs and make the status of every record visible. 2. **Keep data trustworthy**: Audit trails, versioned records and controlled access are designed into every system, so data stays attributable, complete and accurate from capture to report. 3. **Connect research to operations**: Integrations between lab, clinical, manufacturing and ERP systems give teams one consistent view of products, batches and studies. 4. **Make validation less painful**: Traceable requirements, automated tests and repeatable infrastructure give your validation team clear evidence instead of a scramble at the end of a project. ## The pharma solutions we build Whether you need a focused tool for one team or a platform that spans research to market, we cover the full journey: discovery, design, engineering, launch and ongoing support, with a founder accountable at every step. - **Clinical trial systems**: Study management, electronic data capture, patient-reported outcome apps and site portals that keep trial data consistent and every change recorded. - **Quality management tools**: Deviations, CAPAs, change control, training records and document approval workflows with electronic signatures and full history. - **Laboratory systems**: Sample tracking, instrument integrations, results review and custom LIMS extensions that fit how your labs actually work. - **Manufacturing and supply chain software**: Batch records, equipment and material tracking, serialisation data and supply planning tools connected to your ERP. - **Pharmacovigilance and regulatory tools**: Adverse event intake, case processing support, submission tracking and regulatory document management with clear ownership at each step. - **Analytics and reporting**: Dashboards and reporting across research, quality, manufacturing and commercial data, with definitions everyone agrees on. ## Our pharmaceutical domain expertise ### Drug discovery and R&D Early research produces large volumes of experimental, compound and assay data, often scattered across instruments, notebooks and shared drives. We build experiment tracking and compound registration tools, connect electronic lab notebooks and analysis software through APIs, and add scientific search across internal reports and published literature, so researchers can find earlier results quickly and decide what to test next using complete, well-labelled data. ### Clinical trials Sponsors, CROs and sites all touch trial data, and every change has to be attributable to a person and a reason. We build study setup tools and site portals, electronic data capture forms, patient-reported outcome and eConsent apps, and monitoring dashboards that flag missing or inconsistent data early. Integrations with randomisation, safety and trial management systems keep records consistent, with a full audit trail on every entry, correction and signature. ### Manufacturing On the shop floor, paper batch records and disconnected equipment logs slow down batch release and make deviations harder to investigate. We build electronic batch records, equipment and cleaning logs, and tablet apps that guide operators through each step, capture data at source and connect to your MES, ERP and quality systems. Review by exception then lets QA focus on the entries that genuinely need a closer look. ### Quality and regulatory Quality teams manage deviations, CAPAs, change controls, training and controlled documents, often across several tools that do not talk to each other. We build workflows with electronic signatures, role-based approvals and full history, link quality events to the batches and documents they affect, and support regulatory teams with submission tracking and document assembly, all structured around how auditors and inspectors actually examine records. ### Supply chain Medicines have to be traceable from production line to patient, often through temperature-controlled routes and several partners. We build inventory and distribution tools, bring cold-chain sensor and data logger readings into one place with alerting, and exchange serialisation and shipment data with packaging lines, wholesalers and logistics providers through EDI and APIs, so every pack can be located and every temperature excursion investigated with the facts at hand. ### Commercial and medical affairs Field teams, medical science liaisons and medical information services need accurate content and properly recorded interactions. We build CRM extensions and field apps for planning visits and logging conversations, medical information tools that handle enquiries and route possible adverse events to the safety team, and content workflows with review and approval steps, so materials are checked before use and every interaction can be traced later. ## Our approach to pharma software development 1. **Discovery and scoping**: A founder leads the opening workshops: your process, your users, the GxP impact of the system and the platforms it must connect to. You receive a written scope, an outline of user requirements and a price from the engineers who will deliver it. 2. **Design and prototyping**: We map each regulated workflow, the records it creates and who signs what, then test clickable prototypes with scientists, operators or quality staff, so requirements are agreed and traceable before development begins. 3. **Build in short iterations**: Two-week iterations end with working software and updated documentation. Requirements stay linked to automated tests, audit trails and access controls are in place from the first sprint, and every code change is reviewed and recorded. 4. **Validation support and launch**: We prepare controlled environments and supply the specifications, traceability matrix and test evidence your validation team needs. Rollout is planned with your quality team, including data migration checks and training for the people who will use the system. 5. **Support under change control**: After go-live the same team maintains the system within your change control process, assessing the impact of each update, keeping documentation current and building new features as your programmes and sites grow. ## Why develop your pharma software with Authect - **Founders from first workshop to go-live**: The founders who run your first workshop stay on the project through design, build and validation support. There is no handover to a team you have never met, and questions are answered by the people writing the code. - **Built to be validated**: Audit trails, electronic signatures, role-based access and requirements traced to tests are standard in what we build. We work alongside your quality and regulatory teams, who keep responsibility for validation and every GxP decision. - **You own everything**: Source code, documentation, test evidence and infrastructure sit in accounts you control from day one, so your records stay complete and any qualified engineer can maintain the system after us. ## Pharma software development FAQs ### What is pharma software development? It is the design and engineering of software for pharmaceutical companies: systems for research, clinical trials, manufacturing, quality, regulatory affairs and supply chain. Compared with other software, it puts extra weight on data integrity, traceability, validation and controlled change. ### Can you build software for GxP environments and FDA 21 CFR Part 11 or EU Annex 11? Yes. We design for these requirements with audit trails, electronic signatures, access controls, data retention and traceability from requirements to tests. Validation and the decision that a system is fit for GxP use stay with your quality and regulatory teams; we supply the documentation and test evidence they need. ### Can you integrate with our existing LIMS, ERP or quality systems? Yes. We work with vendor APIs, databases and file-based interfaces, and build integrations with validation, retries and monitoring so data moves reliably between systems. Where a platform cannot be extended, we build small services around it rather than forcing a replacement. ### Is cloud hosting suitable for pharmaceutical systems? It can be. We build on major cloud providers with encryption, least-privilege access, logging and infrastructure defined as code, so environments are consistent and changes are reviewable. Whether a given system can run in the cloud is a decision for your IT, quality and regulatory teams, and we design to fit it. ### How do you use AI in pharma software? Mainly to reduce manual work: extracting data from documents, classifying reports, searching scientific and regulatory content, and summarising cases. We keep a person in the loop wherever an output affects a regulated record or a patient, and log what the model produced. ### How long does it take to build a pharma application? It depends on scope and validation needs, but a focused first release usually takes a few months. We agree the smallest useful version, then deliver in short iterations with documentation kept up to date as we go. ## About Authect - Authect is a founder-led software development studio: clients talk to the founders who build their project, never a salesperson. - Every project is led by a senior engineer. Delivery is AI-accelerated, and an engineer reviews every line before it ships. - Clients own their code, infrastructure and designs from day one, with no lock-in. - Legal entity: AUTHECT - FZCO, Trade License No. 70505 (IFZA). Registered office: Building A1, Dubai Digital Park, Dubai Silicon Oasis, Dubai, United Arab Emirates. - The team works in Dubai (Dubai Marina, Business Bay, Dubai Silicon Oasis) and in Spain (Madrid and Marbella), and works with partners in Lithuania. - Clients across Europe, the Middle East and beyond; areas served include Dubai, Madrid, Marbella, Málaga, United Arab Emirates, Spain, Lithuania, Sweden, Norway, Denmark. - Founders: Pranas Mickevicius (Chief Executive Officer), Oscar Arson Saiz (Chief Technology Officer). - Cooperation models: fixed-price projects, monthly sprints, and support and evolution. - Contact: info@authect.com, +971 50 246 5223, or https://authect.com/contact. A founder replies within one working day. - Profiles: LinkedIn https://www.linkedin.com/company/authect/, Instagram https://www.instagram.com/useauthect/, X https://x.com/useauthect, TikTok https://www.tiktok.com/@useauthect, Facebook https://www.facebook.com/profile.php?id=61581141524137.