A robust Quality Control (QC) system is essential for ensuring the safety, efficacy, and consistency of pharmaceutical and biotech products—especially in complex formulations like lipid nanoparticles (LNPs), polymeric carriers, and sterile injectables. We provide comprehensive consulting services to help you build, validate, and scale QC systems that meet global GMP standards and regulatory expectations.

From raw material testing to release and stability assays, our services ensure that your product lifecycle is fully supported by reliable and inspection-ready quality control infrastructure.

Our Quality Control Services

1. QC Strategy Design & System Implementation

We develop and implement integrated quality control systems tailored to your product type, development phase, and regulatory pathway.
Includes:

• Design of phase-appropriate QC systems for preclinical, clinical, and commercial stages
• Integration of analytical methods into QC workflows
• Development of QC standard operating procedures (SOPs)
• Establishment of sampling plans, specifications, and control limits

2. Release Testing & Batch Review Support

Ensure every batch meets regulatory and quality expectations with validated release testing protocols and documentation.
Includes:

• Raw material, in-process, and finished product testing
• Review of batch records, deviations, and test reports
• Setup of specifications for critical quality attributes (CQAs)
• GMP-compliant data review and approval processes

3. Stability Program Design & Execution

We help establish ICH-compliant stability programs to ensure product performance over time and under varying storage conditions.
Includes:

• Stability study design (accelerated, long-term, forced degradation)
• Storage condition planning and time point definition
• Trending analysis and out-of-spec (OOS) investigation support
• Stability protocols for IND, NDA, and commercial requirements

4. Quality Control Team Training & Oversight

Build internal capability with training and technical support for QC personnel, systems, and audits.
Includes:

• QC method training (HPLC, DLS, UV-Vis, LC-MS, etc.)
• Laboratory documentation practices and data integrity principles
• GMP inspection readiness and mock audits
• Cross-functional communication between QC, QA, and manufacturing

Why Partner With Us

• Deep domain knowledge: Specialized in QC for nanoparticle drug products, LNPs, and complex injectables
• Regulatory fluency: Experience with FDA, EMA, and ICH quality guidelines and audit preparation
• Scalable systems: Design QC programs that grow from R&D through commercialization
• Actionable insights: We integrate scientific understanding with operational execution

Ensure Every Batch Meets the Highest Standards

With the right quality control systems in place, you can confidently release safe, effective, and compliant products. Let us help you build a QC foundation you can trust.

📧 Contact us to schedule a consultation and strengthen your quality control infrastructure.