Robust analytical methods are the foundation of quality, compliance, and product understanding in pharmaceutical development. We specialize in developing, qualifying, and validating analytical assays for complex drug delivery systems—including lipid nanoparticles (LNPs), polymeric carriers, and sterile injectable formulations.

Our services ensure your methods are scientifically sound, regulatory-compliant, and fully aligned with your formulation, manufacturing, and clinical strategies.

Our Analytical Development Services

1. Assay Development & Optimization

We design analytical methods tailored to your drug product's unique physicochemical and functional attributes.
Includes:

• Assay selection based on molecule type and formulation
• Method development for size, charge, encapsulation, and purity
• Analytical platforms: HPLC, DLS, UV-Vis, LC-MS, fluorescence, and more
• Optimization of sample prep, run conditions, and sensitivity

2. Method Qualification & Validation

Ensure accuracy, precision, and reproducibility across labs and development phases with ICH-compliant validation.
Includes:

• Method qualification protocols (pre-validation)
• Validation according to ICH Q2(R2) guidelines
• Parameters: specificity, linearity, accuracy, precision, range, and robustness
• Full validation reports and regulatory documentation support

3. Characterization of Nanoparticle-Based Drug Products

We provide advanced characterization for nanoparticle formulations to support release testing, stability, and regulatory submissions.
Includes:

• Particle size and polydispersity index (PDI)
• Zeta potential and surface charge
• Encapsulation efficiency and drug loading
• Stability-indicating method development

4. Regulatory Alignment & Tech Transfer Support

We ensure your analytical methods are compatible with GMP and ready for technology transfer to QC labs or CDMOs.
Includes:

• CMC analytical section authoring for IND/IMPD/NDA
• Method transfer protocols and training
• Inter-lab comparison and bridging studies
• Instrument qualification and SOP creation

Why Choose Us

• Specialized expertise: Deep experience with LNPs, polymeric systems, and injectable nanomedicines
• Regulatory insight: Methods developed with FDA and global submission standards in mind
• Integrated support: Seamless collaboration across formulation, process, and QC teams
• Speed & precision: Efficient development timelines without sacrificing scientific rigor

Build Your Analytical Foundation with Confidence

Whether you're preparing for IND-enabling studies or scaling to GMP manufacturing, we provide the analytical strategy and execution to support your success.

📧 Contact us to schedule a consultation and strengthen your analytical development program.