AXIS CLINICALS LIMITED

AXIS CLINICALS LIMITED is a service provider, specifically a Contract Research Organization (CRO). It is neither a factory nor a trader.

AXIS CLINICALS LIMITED

Company Overview:

AXIS CLINICALS LIMITED is a prominent Contract Research Organization (CRO) based in India. The company is dedicated to providing high-quality and comprehensive clinical research services to the global pharmaceutical, biopharmaceutical, and generic industries. It plays a vital role in supporting drug development by conducting essential studies required for regulatory approvals worldwide.

Business Model:

AXIS CLINICALS LIMITED operates purely as a service provider. Its business model focuses on delivering specialized scientific and technical expertise rather than manufacturing or trading physical products. The company performs various clinical and analytical studies on a contractual basis for its clients.

Key Services Offered:

Bioequivalence and Bioavailability Studies: Conducting comparative studies for generic drug products to demonstrate therapeutic equivalence.

Clinical Trials: Managing and executing Phase I to Phase IV clinical trials across various therapeutic areas.

Pharmacokinetic and Pharmacodynamic Studies: Analyzing the behavior of drugs in the body, including absorption, distribution, metabolism, and excretion.

Bioanalytical Services: Developing and validating analytical methods and performing sample analysis for drug and metabolite quantification.

Data Management and Biostatistics: Providing robust data management solutions and expert statistical analysis for clinical study data.

Regulatory Affairs Support: Assisting clients with regulatory submissions and ensuring compliance with international guidelines.

Facilities and Standards:

The company typically operates advanced clinical pharmacology units and state-of-the-art bioanalytical laboratories. It adheres strictly to international regulatory guidelines such as Good Clinical Practice (GCP), Good Laboratory Practice (GLP), and Good Documentation Practice (GDP). AXIS CLINICALS LIMITED often undergoes regular inspections and approvals from leading global regulatory authorities including the US FDA, MHRA (UK), ANVISA (Brazil), WHO, and the DCGI (India), ensuring the highest quality and integrity of its research.

Mission:

To accelerate the drug development process for its global partners by providing ethical, efficient, and scientifically sound clinical research solutions.

Based on available information, AXIS CLINICALS LIMITED (India) primarily focuses on:

* In-vitro diagnostic reagents

* Rapid diagnostic kits

* Clinical chemistry analyzers

* Hematology analyzers

* ELISA kits

* Molecular diagnostics products

* Point-of-care testing devices