CDMO Suite
R&D & Manufacturing Integrated Platform
An end-to-end digital platform for Contract Development and Manufacturing Organizations (CDMO / CRO) with multi-client isolation, from process development to GMP manufacturing. Supporting the WuXi AppTec / Pharmaron model — a single instance handles 500+ concurrent projects with deep IP protection and optional ITAR compliance, enabling efficient project delivery while ensuring client data security.
Six Core Capabilities
Built for the unique characteristics of CDMO/CRO operations — from client management to GMP manufacturing, covering the complete contract development and manufacturing value chain.
Multi-Client Multi-Project Management
Client isolation, project sandboxes, IP protection — a single instance supporting 500+ concurrent projects. Each client has an independent workspace with data, processes, and permissions fully isolated to prevent cross-contamination risks. Client self-service portal for real-time project progress and deliverable tracking.
Process Development (PD)
DoE experimental design and statistical analysis, process parameter optimization (QbD/PAT), scale-up simulation and risk assessment. Full-chain process knowledge accumulation from lab-scale to pilot-scale, with automatic process development report and transfer package generation.
GMP Manufacturing Integration
Electronic Batch Records (EBR), material balance calculation, MES / DCS integration, production scheduling and resource allocation. Achieving a full GMP compliance closed loop from WIP to finished product release, with batch record review cycle reduced by over 60%.
Client Collaboration Portal
Project progress visualization dashboards, data sharing with online approval, electronic signatures, secure audit trails. Clients can self-serve milestone tracking, view test reports, and submit change requests — reducing email correspondence and communication costs by 80%.
Technology Transfer & Scale-Up
Technology transfer package generation, gap analysis and risk assessment, training tracking and competency verification. Supporting structured tech transfer from R&D to pilot, and pilot to GMP manufacturing — ensuring complete knowledge transfer with controlled risks and traceable compliance.
Intellectual Property Protection
Data encryption, fine-grained access auditing, physical/logical client-to-client isolation, optional ITAR/EAR compliance. Full-chain operation logging supporting client audits and regulatory reviews — giving sponsors the confidence to entrust core IP to your development and manufacturing.
Twelve Functional Modules
End-to-end coverage of the complete CDMO/CRO business chain — from client onboarding to project delivery, every stage is supported by specialized modules.
01 Client Management
Project sandboxes / IP isolation / client hierarchy
02 Project Initiation
Quotation / contracts / milestone planning
03 Process Development
DoE / PAT / QbD experiment management
04 Analytical Methods
Development / validation / transfer lifecycle
05 GMP Manufacturing
EBR / material balance / production scheduling
06 Quality Release
OOS / CAPA / QP release review
07 Stability Studies
ICH guidelines / accelerated / long-term stability
08 Client Portal
Progress dashboards / document sharing / online approval
09 Tech Transfer
Process package / training / validation management
10 Knowledge Management
Formulation / experience / process knowledge retention
11 Regulatory Filings
IND / NDA / DMF filing support
12 Data Security
Encryption / fine-grained auditing / ITAR
Five-Layer Platform Architecture
A five-layer pluggable architecture designed for CDMO multi-tenant scenarios — each layer independently scalable and upgradeable to meet deployment needs of CDMOs at any scale.
Multi-Endpoint Collaboration
Internal Web App · Client self-service portal (white-labeled) · Mobile approval (WeCom/DingTalk) · Open API for client system integration
CDMO Core Business Engine
Client & contract management · Project initiation & milestones · Process development workflows · GMP batch record engine · Quality event management · Regulatory filing management · Client billing & settlement
Multi-Tenant Resource Orchestration
Tenant isolation engine (logical/physical selectable) · Permission and data tiering model · Configurable workflow engine · Notification & approval routing · Cross-project resource scheduling
Domain Data & Compliance Foundation
Project data warehouse (PostgreSQL/MPP) · Document knowledge base (vector index + full-text search) · Audit trail (blockchain optional) · Electronic signatures (21 CFR Part 11 compliant)
Deployment & Integration Base
Public / private / hybrid cloud deployment · MES / DCS / ERP bi-directional integration · Domestic platform adaptation (Xinchuang certified) · SOC 2 / ISO 27001 security baseline
Build a Digital Foundation for Your CDMO Business
Book a 30-minute online demo and receive a tailored solution with ROI assessment for your business scale.
We serve 60+ CDMO/CRO clients across biopharmaceuticals, chemical synthesis, and medical devices.