Cloud for Life Science
& Pharma — on AWS
Storm Reply empowers pharma and life science companies: GxP-compliant cloud infrastructure, AI-driven drug discovery, and regulatory-grade data management on AWS.
From Compliance to AI-Driven Research
Our structured approach guides pharma and life science companies from the regulatory foundation to data-driven innovation on AWS.
Regulatory Assessment
Analysis of the existing system landscape, data classification, identification of GxP scope, and development of a CSV strategy for the cloud.
GxP Infrastructure
Building a validated, GxP-compliant AWS infrastructure with audit trails, access control, data encryption, and immutable data storage.
Data Migration & CSV
Validated migration of clinical and analytical data with complete documentation per GAMP 5 and Validation Summary Report.
AI & Analytics
Implementation of ML models for drug discovery, real-world evidence, and clinical data analysis on validated AWS services.
Managed Compliance
Continuous compliance monitoring, change control processes, audit preparation, and operations per regulatory requirements.
Our Core Services
Specializing in the most complex regulatory and technological challenges facing the pharma and life science industry on AWS.
GxP Compliance & CSV
Validation of cloud systems per GxP requirements (GMP, GCP, GLP) and Computerized System Validation (CSV) per GAMP 5. Complete documentation, audit trails, 21 CFR Part 11, and EU GMP Annex 11 on AWS.
Drug Discovery & Genomics
AI-driven drug research on AWS: genomic data analysis with AWS HealthOmics, molecular design with Amazon SageMaker, and generative AI for identifying drug candidates with Amazon Bedrock.
Real-World Evidence
Analysis of patient data from electronic health records, insurance claims, and wearables on FHIR-compliant infrastructure. Privacy-compliant multi-party analysis with AWS Clean Rooms under GDPR and ICH E8.
Medical Device & MDR
Development and qualification of Software as a Medical Device (SaMD) per MDR 2017/745 and IEC 62304. Storm Reply supports risk classification, technical documentation, QMS integration, and post-market surveillance on AWS.
Clinical Trial Data Management
Secure, scalable platforms for clinical trial data (EDC, CTMS, eTMF) on AWS. CDISC-compliant data models, real-time monitoring, and regulatory submission pipelines for FDA and EMA per ICH E6(R3).
Successful Life Science Projects
Measurable outcomes from Storm Reply cloud transformation projects in the pharma and life science industry.
Faster Drug Discovery Pipelines
AI-driven drug research on AWS with Amazon SageMaker and AWS HealthOmics reduced the cycle time of screening campaigns by 60% — from months to weeks.
GxP Compliance from Day One
Build-out of a fully validated GxP-compliant AWS platform with CSV documentation, audit trails, and 21 CFR Part 11 compliance — zero findings at FDA inspection.
More Patient Data for RWE
FHIR-compliant data platform on Amazon HealthLake enabled integration of three times as many data sources for real-world evidence studies — with full GDPR compliance.
MDR Certification Accelerated
Structured MDR documentation and QMS integration on AWS shortened the certification process for a SaMD product by 6 months compared to the industry average.
Customers & Partners
Cloud transformation for leading pharma, biotech, and medtech companies across DACH and beyond.
Consulting Partner Since 2014
Competency Data Protection & Compliance
Competency Data & Analytics Partner
Recognized Expertise on AWS
Your Strategic AWS Premier Partner
Storm Reply is the AWS-specialized company within the Reply Group — holding the highest AWS partner status: Premier Tier Services Partner since 2014. In the DACH market, we guide businesses from strategy through migration to ongoing operations.
As part of the Reply Group, you benefit from 16 AWS Competencies, 1,500+ AWS certifications, and a network of over 2,000 AWS professionals — across 6 locations in Germany.
FAQ on Pharma Cloud on AWS
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GxP refers to Good Practice frameworks such as GMP (Good Manufacturing Practice), GCP (Good Clinical Practice), and GLP (Good Laboratory Practice). GxP compliance in the cloud means that systems, processes, and data meet the regulatory requirements of the pharmaceutical industry — including 21 CFR Part 11 (electronic records), EU GMP Annex 11, and audit trails. AWS provides validatable infrastructure and Storm Reply implements GxP-compliant architectures with Computerized System Validation (CSV).
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AWS offers specialized services for drug discovery: Amazon SageMaker for ML models in drug research, AWS HealthOmics for genomic data, and Amazon Bedrock for generative AI models. Storm Reply implements end-to-end pipelines — from target identification through molecular design to clinical data management — on a GxP-compliant, scalable cloud infrastructure.
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Real-World Evidence refers to insights derived from patient data outside clinical trials — from electronic health records, insurance claims, or wearables. AWS provides Amazon HealthLake for structured health data (FHIR-compliant), Amazon SageMaker for statistical analysis, and AWS Clean Rooms for privacy-compliant multi-party data analysis in accordance with GDPR.
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The EU Medical Device Regulation (MDR 2017/745) classifies software as a medical device (SaMD — Software as a Medical Device) when used for diagnosis or therapy. For cloud-based medical devices, this means: risk classification, technical documentation, QMS per ISO 13485, IEC 62304 for the software lifecycle, and post-market surveillance. Storm Reply supports MDR-compliant development and qualification of AWS-based medical devices.
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Migration of clinical trial data to AWS follows a validated process: data classification and data protection impact assessment (DPIA), encryption with AWS KMS, use of Amazon S3 with Object Lock for immutable data storage, audit trails with AWS CloudTrail, and access control with AWS IAM. Storm Reply ensures compliance with GCP, GDPR, and ICH E6.
Ready for the Pharma Cloud?
Our life science experts advise you on GxP-compliant infrastructure, drug discovery on AWS, and regulatory-grade data management.
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