Method strategy
Select the analytical platform, acceptance criteria, and validation plan that fit the molecule and market.
CMC Analysis & Quality Control
GMP-ready quality control for global product release
Analytical development, validation, stability, batch release, and impurity testing across small molecules, TIDES, biologics, biosimilars, and advanced therapies.
Quality Control Portfolio
Specialized CMC services mapped to every release and compliance need
Use the capability cards below to open the corresponding detailed page.
Method Development & Validation
Robust analytical methods designed for transfer, validation, and regulated use.
Explore capability ->Raw Material Testing
Supplier qualification and incoming raw material testing for critical inputs.
Explore capability ->QC of Small Molecules
Release and stability testing for API and finished dosage forms.
Explore capability ->QC of Oligonucleotides
Identity, purity, sequence, and impurity testing for TIDES workflows.
Explore capability ->QC of Biologics
Biologics characterization, potency, purity, and stability testing.
Explore capability ->Biosimilar Comparability
Comparability packages supporting biosimilar development and submissions.
Explore capability ->Batch Testing & Release
Fast, controlled release testing with clear documentation and data integrity.
Explore capability ->Viral Vector Characterization
AAV, lentivirus, and vector-specific analytical characterization.
Explore capability ->Stability Studies
ICH-aligned stability programs, storage, pull points, and reports.
Explore capability ->Transdermal Testing
IVRT/IVPT and performance testing for topical and transdermal products.
Explore capability ->Microbiology
Microbial quality, sterility-related support, and contamination control testing.
Explore capability ->Elemental & Nitrosamines
Trace impurity testing for elemental impurities, nitrosamines, and related risks.
Explore capability ->Extractables & Leachables
Risk-based E&L studies for container closure, devices, and process contact materials.
Explore capability ->Inhaled & Nasal Products
Product-specific testing for orally inhaled and nasal drug products.
Explore capability ->Cell-Based Potency
Functional potency methods and cell-based assay support.
Explore capability ->Controlled Execution
From analytical strategy to compliant release documentation
CMC programs need reproducible methods, reliable timelines, and clean quality records. BrownBiology combines specialized instrumentation with a quality culture built for regulated submissions.
Validation and transfer
Execute validation, robustness checks, and transfer-ready documentation.
Release and lifecycle support
Run batch, stability, impurity, comparability, and investigation support as the program scales.
