• AXIS Clinicals successfully completes 20th US FDA audit (April 2017)
  • AXIS Clinicals successfully completes 8th ANVISA – Brazil audit (August 2017)
  • AXIS Clinicals successfully completes MCC South Africa audit (March 2017)
  • AXIS Clinicals successfully completes GCC audit (February 2016)
  • AXIS Clinicals successfully completes 7th ANVISA – Brazil audit (March 2015)
  • AXIS Clinicals successfully completes WHO audit (March 2015)
  • AXIS Clinicals successfully completes 3rd MHRA audit (Sep 2014)
  • BA-BE studies conducted at AXIS Clinicals are accepted by Chile – ISP

Bio-Analytical Services :

We have a decade long experience in offering comprehensive range of Bio-Analytical services, advanced facilities, equipments and highly-trained personnel for custom method development, assay validation, and sample analysis using modern LC/MS/MS and ICP-OES equipment to support Pharmaceutical NCE and Generic Drug Development.

AXIS has the competency to handle liquid-liquid extractions, solid-phase extractions and pre-column | post-column derivatization procedures, Chiral separation of optical isomers as well as Conjugate and non-Conjugate drug level estimation.

The Bio-Analytical Team has developed a deep understanding of the specific regulatory requirements of international regulatory agencies such as FDA, EMEA, ANVISA, WHO, MCC, TGA and DCGI.

Our method data bank has over 350+ new drug assays, with the standards set by international regulatory authorities.

Method Development and Validation

All analytical methods developed and validated at AXIS Clinicals are compliant with latest international regulatory requirements with assurance of precision recovery and stability checks. We offer the flexibility and specialized expertise to either transfer your clinical assay or develop a method from scratch and validate the assay for the bio-analysis in a cost effective and timely manner. Our staff has developed Bio-Analytical methods including routinely quantifying levels in pg/ml.

AXIS has developed 350+ validated assays for multiple analytes, metabolites, prodrugs and light and temperature-sensitive compounds in various biological matrices. Using the literature support and experience in similar molecules, our method development team discusses and develops the research plan. We have developed First‐in‐Asia Critical Assays for small molecules such as:

  • Conjugated Estrogen
  • Esterified Estrogens
  • Estradiol
  • Ethinyl Estradiol & Levonorgestrol
  • Many combinations of Oral Contraceptives

AXIS Clinicals has developed First‐in‐world Assays for small & large molecules such as:

  • Loteprednol in Aqueous Humor
  • Dexamethasone in Aqueous Humor
  • Testosterone in serum

 

AXIS has Critical Assay in development and validation stage for First-To-File Products such as:

  • Insulin
  • Glucagon
  • Enoxaparin

All the method validations are performed according to Good Laboratory Practices (GLP), regulatory guidance and in-house SOPs to ensure that the developed assays demonstrated linearity, recovery, reproducibility, specificity, accuracy and stability under all conditions.

Bio Sample Analysis
Our significant expertise in stringent Bio-Analytical methodologies and processes promises the fast and rapid sample processing throughput and quality data. The scientists at AXIS Clinicals perform Bio analysis in line with international regulatory requirements with constant check from In Process Quality Control Team. We are performing Incurred Sample Reanalysis (ISR) in strict compliance with the protocol and regulatory requirement.

Infrastructure

Hyderabad

Our modern accredited Central Bio-Analytical facility located in Hyderabad includes:

  • 25 LC-MS/MS (SCIEX API 2000, 3000, 3200, 4000,4500,5500 and 6500+)
  • 5 HPLC-UV/Fluorescent Detectors
  • 2 ICP-OES for Trace Metal Analysis
  • 25,000 square-foot bio-analytical area
  • Networked Chromatographic Data Management (Scientific Data Management System NuGenesis®)
  • Spacious Sample Preparation Labs
  • Solid Phase Extraction Systems (96, 48 well plated)
  • Nitrogen Evaporators
  • Refrigerated Centrifuges
  • Large Walk in Freezer (-20°C) and Deep Freezers (-70°C)
  • Automatic temperature recording device
  • Dedicated Servers for LCMS/MS data

All our systems use validated software that is 21 CFR Part 11 compliant.  The Bio-Analytical data is electronically transferred and documented. All studies are scrutinized by the QA Department and subjected to periodic in-house audits to ensure compliance.

All study samples at AXIS Clinicals are stored in secure freezers with temperatures ranging from 2°- 8° C - 20° C and -80° C. These freezers are monitored round the clock with power backup.

Mexico

Our modern accredited Bio-Analytical facility located in Mexico City includes:

  • 4 LC-MS/MS (SCIEX API 3000, 3200 and 4000)
  • 15000 square-foot bio-analytical area
  • Plans to augment infrastructure through additional LCMS/MS & HPLC’s in phases
  • Networked Chromatographic Data Management (Scientific Data Management System NuGenesis®)
  • Spacious Sample Preparation Labs
  • Solid Phase Extraction Systems (96, 48 well plated)
  • Nitrogen Evaporators
  • Refrigerated Centrifuges
  • Deep Freezers (-20°C and – 70°C)
  • Automatic temperature recording device
  • Dedicated Servers for LCMS/MS data

 

 

 

Fact sheet

  • 2,600+ clinical studies completed since inception
  • 350+ bioanalytical methods developed
  • 50+ successful Regulatory audits
  • Global footprint of operations with sites in India, U.S & Mexico.
  • Two clinical facilities (Hyderabad & Ahmedabad) in India
  • 100+ National and International Pharma/Biotech Sponsor companies working with AXIS
  • US FDA : 500+ approvals, EMEA : 100+ approvals, Canada : 50+ approvals, Australia : 50+ approvals
  • 500+ experienced employees working globally
  • Huge database of patient population in various therapeutic areas viz. Cardiology, Opthalmology, Schizophrenia, Diabetology, Oncology. Orthopedics etc..

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