• AXIS Clinicals successfully completes 20th US FDA audit (April 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

BA | BE Studies

At AXIS, we share your passion for the advancement of medicine and understand the need for innovative solutions to accelerate your product’s time to market. Exceptional team chemistry and dedication to service are the hallmarks of our workforce.

We, the premier service provider of Clinical Pharmacology Services, specialize in providing safe and ethical research solutions for Bioequivalence - Bioavailability studies.

Our domineering experience in conducting a full range of bioavailability / bioequivalence clinical studies has given us a complete understanding of the generic development process, which gives confidence to our sponsors that the outsourced project will be completed professionally and with most expeditious economic way possible. Our large infrastructure ensures the quick accommodation of your project for male / female or special populations.

The pharmacokinetic, bioavailability and bioequivalence studies are conducted at our facilities in strict compliance with national and international regulatory guidelines that are monitored by independent quality assurance team. With fewer levels of management, our staff members are able to respond quickly to a client’s request and initiate action without having to consult a committee. Our team members take ownership of the project, providing clients with a more personalized, strategic approach to clinical management in the context of the phase, location and objectives of the study.

At AXIS Clinicals, we offer specialized services in the following types of studies:

  • Fasting and Fed condition
  • Single and multiple dose in healthy subjects
  • Drug-drug interaction, drug-food interaction
  • Various Routes of Administration
  • Special | Patient Population (PK | PD) studies

 

Our expertise with various formulations includes but not limited to:

  • Solid Oral Formulations Tablets, Capsules, Soft Gels, Sprinkles, IR, ER, DR and SR
  • Orally Dispersible Formulation
  • Liquid Formulations Suspensions & Syrups
  • Parenterals Intra Muscular, Intra Venous & Subcutaneous
  • Transdermal Gel
  • Sprays Nasal & Oral
  • Metered Dose Inhaler, Dry Powder Inhaler
  • Dermal Patches
  • Skin Blanching Studies

The volunteer recruitment team utilize proven modus operandi for mobilizing the study participants for your clinical studies. Vigilant screening and volunteer assessment methodology have created an extensive database of 50000+ volunteers for your studies. Our huge database includes the special population like:

  • Healthy Females with child-bearing potential
  • Elderly subjects
  • Hypogonadal males
  • Obese subjects

Infrastructure - Clinical Pharmacology

Hyderabad

Our clinical pharmacology unit (CU-I) is equipped with:

  • 192 beds arranged in four clinic study areas to accommodate studies in fewer or no cohorts
  • 25,000 square-foot clinic area
  • Four-bed Intensive Care Unit with continuous cardiac monitoring
  • 24/7 medical surveillance
  • Dedicated phlebotomists
  • Dedicated phlebotomists
  • Experienced physicians, nurses and clinical staff
  • Refrigerated Centrifuges
  • Humidity Chambers
  • -30°C and -80°C storage facility
  • Direct access to AXIS Clinicals Central Bio-Analytical facility
  • On-site Protocol Development and Medical Writing

 

Ahmedabad

Our clinical pharmacology unit is equipped with:

  • 138 beds arranged in five clinic study areas to accommodate mixed-gender studies
  • 30,000 square-foot clinic area
  • Intensive Care Units with continuous cardiac monitoring
  • 24/7 medical surveillance
  • Dedicated phlebotomists
  • Experienced physicians, nurses and clinical staff
  • Refrigerated Centrifuges
  • Humidity Chambers
  • -30°C and -80°C storage facility

Mexico

Our clinical pharmacology unit is equipped with:

  • 132 beds arranged in four clinic study areas
  • 40,000+ square-foot clinic area
  • Central Intensive Care Unit with continuous cardiac monitoring
  • 24/7 medical surveillance
  • Dedicated phlebotomists
  • Experienced physicians, nurses and clinical staff
  • Refrigerated Centrifuges
  • Humidity Chambers
  • -30°C and -80°C storage facility
  • Direct access to AXIS Clinicals Bio-Analytical expertise

USA

  • 180 Beds in CPU
  • 1,20,000 sq. ft area (Dilworth, MN)
  • Dedicated Dermatology Research Center
  • Expertise in Derma and Controlled substances
  • World-class infrastructure to support the America market & other Regulated markets.
  • DEA Licensed Pharmacy - Locked Vault & Temperature/Humidity Control

Fact sheet

  • 2,400+ 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+ experianced employees working globally
  • Huge database of patient population in various therapeutic areas viz. Cardiology, Opthalmology, Schizophrenia, Diabetology, Oncology. Orthopedics etc..

Copyright Axis Clinicals - All Rights Reserved