Life Sciences: Pharma/Biotech
From the First Molecule to Commercial Scale
Whether you’re a precommercial biotech building your operational foundation or a commercial pharmaceutical company scaling global manufacturing, Answerthink® will help you deploy SAP in a way that’s right for your stage (and what comes next).
Infrastructure can’t wait for success
Pharmaceutical and biotech companies face a challenge that few other industries encounter: the systems and processes you need to be a commercial-stage company must be in place before you become one. FDA scrutiny, investor due diligence, contract manufacturing organization (CMO) partnerships and commercial launch don’t wait for your infrastructure to catch up. The cost of building too late (or building the wrong foundation too early) can delay launches, jeopardize compliance and leave growth on the table.
Answerthink® works with pharma and biotech organizations at every stage of the development continuum. We bring the SAP expertise and life sciences depth to help you build the right foundation at the right time – scalable enough to grow with you, compliant enough to satisfy regulators and lean enough to match where you are today.
Spotlight
The Moderna story
When Answerthink® began working with Moderna, they were a little-known biotech startup. Years later, when the federal government invested $18 billion to deploy Moderna’s mRNA COVID-19 vaccine at global scale, the SAP foundation was ready.
“Without knowledge of COVID-19 even coming down the line, Moderna was able to support the transition from a startup to a leader in the vaccine market.” – Tom Reul, Answerthink®
Know where you are and know what comes next
SAP isn’t a one-size-fits-all deployment. The right solution depends on where you are in your journey – and where you’re headed. Here’s how we think about it:
Outcomes we deliver
Validation-ready implementation
Answerthink® delivers every SAP implementation with a structured validation approach built for regulated environments – following GAMP 5 principles and the FDA’s risk-based Computer Software Assurance (CSA) direction.
Our process includes:
We work with a leading life sciences validation specialist to support clients through both initial validation and long-term compliance continuity.
SAP capabilities for pharma/biotech
Answerthink® supports SAP Cloud ERP deployment models, helping regulated clients choose the architecture that fits their compliance posture, IT strategy, and timeline. SAP’s platform is built to support the specific compliance and operational demands of regulated pharmaceutical and biotech environments:
- Validated processes and electronic records that meet 21 CFR Part 11, cGMP, and GxP requirements at every stage
- Support data integrity requirements aligned with ALCOA+ principles (attributable, legible, contemporaneous, original, accurate, complete, consistent, enduring, available) – a high-priority focus for FDA and global regulatory agencies
- Integrated quality management for deviations, CAPAs, change controls and complaint handling
- SAP Batch Release Hub – automating batch disposition decisions, release workflows, and electronic signatures to reduce cycle times, minimize human error, and maintain a complete release audit trail
- End-to-end batch traceability from raw material receipt through manufacturing, release and distribution
- SAP Advanced Track and Trace for Pharmaceuticals (ATTP) for serialization, DSCSA compliance, and EPCIS-based electronic traceability
- Serialization and track-and-trace capabilities that satisfy DSCSA and international market requirements
- Supply chain planning and CDMO collaboration across a single, connected network
- Scalable financial and revenue management for companies transitioning from R&D cost centers to commercial profit and loss (P&L) operations
- Research and development (R&D) program costing and milestone tracking to manage investor-facing financial visibility across development programs, plus SAP Revenue Accounting and Reporting (RAR) for milestone payments and licensing revenue recognition
- Integration with pharmacovigilance and drug safety systems – connecting SAP operational data with the safety platforms that manage adverse event reporting and regulatory submissions
- Integration with existing technology platforms – including MES, and LIMS systems – ensuring compliant data continuity across your full technology stack rather than replacing the tools you already run
With SAP, life sciences companies gain a single, compliant digital core capable of supporting today’s demands and tomorrow’s innovation.
Life Sciences Insights and Resources
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Building something that needs to scale?
Start the conversation now.
Whether you’re in clinical trials or already commercial, Answerthink®
can help you assess where you are, identify the gaps, and build an SAP
roadmap that fits your stage and your ambitions.