Development & optimization
Chromatography, detection, sample preparation, system suitability, and stress-informed selectivity.
← CMC ServicesAnalytical Lifecycle
Method Development & Validation
Development, optimization, qualification, transfer, and validation of analytical methods for APIs, drug products, biologics, oligonucleotides, and complex formulations.
ICH-alignedSpecificityAccuracyPrecisionRobustness
Methods that survive real samples and regulatory review.
rebirthBiology develops analytical procedures around product attributes, matrix challenges, specification needs, and lifecycle stage. Validation packages are structured for GMP use and global regulatory expectations.
Qualification
Fit-for-purpose performance checks for early development, comparability, and investigational materials.
Validation
Specificity, linearity, range, accuracy, precision, quantitation limits, robustness, and solution stability.
Transfer & troubleshooting
Method transfer protocols, receiving lab support, deviation investigation, and performance remediation.
Why Choose
Lifecycle control, not one-off paperwork.
Product-aware design
Methods are linked to critical quality attributes and specification strategy.
GMP documentation
Protocols, raw data, reports, and traceability are built for quality review.
Cross-modality experience
Small molecules, peptides, oligonucleotides, biologics, and complex dosage forms are supported.
Move your method toward GMP readiness.
Send the draft method, product type, target attributes, and validation objective.
Discuss Method Validation