R&D & Manufacturing Services
Integrated research, development, and GMP-oriented manufacturing workflows designed to accelerate product readiness while maintaining audit-ready documentation and data integrity.
Development
Manufacturing
Controls
Alignment
Service Overview
End-to-end support from lab-scale R&D through validation and manufacturing readiness with traceability, controlled documentation, and scalable processes.
- Process Development & Optimization
- Analytical Method Development & Validation
- Pilot Batches & Tech Transfer
- GMP Documentation & SOPs
R&D and Manufacturing Capabilities
Structured workflows and controls aligned to cGMP and data integrity principles.
Analytical Development
Methods & Validation
Design and validation of robust analytical methods for quality control and release testing.
Process Development
Optimization
Experimental design and optimization for scalable, reproducible manufacturing processes.
Pilot Manufacturing
Batches & Transfer
Pilot batch execution, tech transfer documentation, and readiness for GMP production.
QA/QC & Documentation
Controls
SOPs, batch records, and audit-ready documentation aligned to data integrity principles.
Regulatory Alignment
Compliance
cGMP-oriented workflows with traceability and controlled access for manufacturing readiness.
R&D → Manufacturing Process
A structured pathway from concept to manufacturing readiness with quality and traceability embedded throughout.
Concept & Feasibility
Initial design, feasibility, and risk assessment.
Lab Development
Method development and iterative optimization.
Scale-Up
Process scale-up with validation planning.
Pilot & Transfer
Pilot batches and tech transfer documentation.