The Analytical Quality Services (AQS) unit — the engine room behind every dossier Airis files.
Analytical development is where complex generic programs are won or lost. Methods that hold up at validation, dissolution profiles that match the reference, impurity work that survives FDA review — this is the science that determines whether a dossier files clean or stalls in deficiency cycles. Airis's analytical laboratory has supported regulated-market filings since 2014, with two USFDA inspections cleared and a track record built molecule by molecule.
End-to-end method science across the complex generic lifecycle.
Method Development
Discriminating, stability-indicating methods purpose-built for each molecule.
- Screening through validation-ready protocols
- Stability-indicating by design
- Engineered to survive transfer
Method Validation, Qualification & Transfer
End-to-end execution aligned with ICH Q2(R1), USP <1225>, and FDA guidance.
- Validation, verification, qualification
- Transfer to receiving labs with full data continuity
- Regulator-defensible documentation
Stability Studies
ICH-aligned programs across long-term, accelerated, and intermediate conditions.
- Walk-in & reach-in chambers · 5 units
- 40°C/75% RH · 30°C/75% RH · 25°C/60% RH
- Photostability · stand-alone studies available
Dissolution & Release Testing
Discriminating dissolution development and routine release on qualified USP apparatus.
- Modified-release & BCS II/IV programs
- BE strategy support
- Post-approval change defense
Impurity Profiling & Chiral Analysis
ID, quantification, and structural confirmation across related substances and degradants.
- ICH Q3A / Q3B / Q3D thresholds
- Chiral separation for stereo-specific molecules
- Elemental impurities
Raw Material, In-Process & Finished Product Testing
Full physicochemical testing across the complex generic supply chain.
- APIs, excipients, packaging
- In-process and finished product release
- Pre-registration through commercial cGMP batches
Supporting services across scale-up, regulatory, and clinical.
Scale-Up & Tech Transfer Support
Analytical method science travels with the program. When a partner moves from R&D to clinical to commercial scale, our methods, specifications, and reference standards transfer cleanly to the receiving site — preserving years of accumulated learning instead of forcing a rebuild.
Regulatory & Filing Support
Direct support for product registration dossiers across USFDA, MHRA, Health Canada, and emerging markets — including analytical sections of CTD modules, response to deficiency letters, and post-approval change defense.
Clinical & BE Support
Bioanalytical method support for bioequivalence and clinical programs, with continuity of analytical thinking from formulation development through pivotal BE study readout.
Three reasons co-development partners route their hardest analytical work to us.
USFDA-registered, twice-cleared
The lab is registered with USFDA (FEI 3012071812; DUNS 650864775), with registration valid through December 2026. Two USFDA inspections — Jan 2017 (NAI · Zero 483) and Feb 2024 (VAI · EIR received) — both cleared. The lab is also audited and approved by CDSCO.
Methods that hold up at transfer
Our method development isn't just about getting a clean chromatogram in our lab — it's about building methods robust enough to survive transfer to partner QC sites without rework. That's the difference between a method that closes one filing and a method that scales across a franchise.
One accountable lab across the lifecycle
API testing, in-process control, finished product release, stability, and BE-supporting bioanalytics — all under one regulator-audited roof. Partners don't manage multiple analytical vendors with conflicting timelines and inconsistent documentation standards.
A fully qualified instrument fleet — supporting USFDA-grade analytical work end-to-end.
Our analytical laboratory operates a fully qualified instrument fleet across chromatography, spectroscopy, dissolution, and stability — supporting regulated-market analytical work end-to-end:
- Shimadzu HPLC systems · 8 units · UV, RI, and PDA detection
- Headspace Gas Chromatography
- FTIR Spectrometer · UV Spectrophotometer
- Dissolution Test Apparatus · USP-compliant
- Disintegration Test Apparatus · 3 units
- Karl Fischer Apparatus & Auto-Titrator
- Walk-in & reach-in stability chambers · 40°C/75% RH · 30°C/75% RH · 25°C/60% RH · 5 units
- Photostability, humidity, cooling chambers & deep freezer
- Friability, hardness & tap density testers
- Laminar air flow cabinet · water purification system
- Analytical balances, muffle furnace, moisture analyzer, pH meters, sieve shaker
Airis operates under a risk-based Quality Management System purpose-built for cGLP analytical services. The QMS spans qualifications and validations, change management, training, document control, customer complaints, OOS/OOT investigations, CAPA, and outsourced-activity audits — designed to deliver compliance that holds up under regulator scrutiny.