- Quality
Precision engineering aligned with regulatory integrity.
- Overview
Quality Assurance & Quality Control Peptide & Biologics CRO/CDMO
Our integrated Quality framework ensures data integrity, regulatory alignment, and reproducible outcomes across peptide and biologics discovery, development, and early-stage manufacturing programs. We apply a risk-based, phase-appropriate Quality Management System aligned with global regulatory expectations.
Services Offerings
Quality Assurance (QA)
Quality Assurance provides governance and oversight to ensure all activities are performed in a controlled, compliant, and traceable manner. Our QA system includes controlled documentation, change control, deviation and CAPA management, risk assessment aligned with ICH Q9, role-based training, and internal audits.
Quality Control (QC)
Quality Control ensures the scientific and analytical integrity of materials and data. QC activities include analytical method development and qualification, in-process and final testing, impurity profiling and reference standard support, and stability assessment.
Peptide & Biologics Focus
Peptides & Oligonucleotides: sequence fidelity, impurity control, analytical robustness, scalability readiness.
Biologics: process consistency, comparability, characterization, and data reliability for regulatory progression.
Data Integrity & Compliance
All data is managed according to ALCOA+ principles, ensuring accuracy, traceability, and reliability. Quality systems align with applicable GLP and GMP principles and relevant ICH guidelines (Q7, Q8, Q9, Q10).
Frequently Asked Quesions
Our custom peptide synthesis services include advanced solid phase peptide synthesis (SPPS) with high-purity reagents and comprehensive in-house control. We specialize in challenging sequences, long-chain peptides, complicated alterations, and multi-chain structures while maintaining worldwide compliance, consistency, and high yields.
Yes. Our peptide synthesis service accommodates all production scales, from small R&D batches to kilogram-level commercial output. We provide safe, pure, and regulatory-compliant peptides using GMP-ready procedures, sophisticated chromatography, and tailored purification systems.
Absolutely. We specialize in creating custom peptides, such as unnatural amino acids, pegylated compounds, cosmetic peptides, and multi-chain peptide APIs. Each project goes through optimized synthesis, efficient cleavage, and high-performance purification.
Our solid phase peptide synthesis workflows are based on ultra-pure Fmoc amino acids, sophisticated peptide resins, optimized chemical cycles, and stringent analytical testing. This enables high recovery rates, low contaminants, and consistent batch performance.
Yes. We use solid phase peptide synthesis to create rationally designed analogue libraries, which allow for SAR research, potency optimization, and quick screening. These programs work perfectly with our custom peptide synthesis services.