Bioequivalence Studies

Product description

BE studies between products are required for supporting certain changes before approval for a pioneer product in NDA, as a part of ANDA submissions and for certain post approval changes.Important Features:
  • State-of-the-art analytical facilities having 84 beds
  • Successfully completed more than 200 BE Studies
  • More than 120 validated Methods
  • Facility approved by NPRA, Malaysia and DCGI
  • Accredited from CDSCO, India
  • Expertise in bioequivalence studies in healthy volunteers including female studies and also in patients studies
  • Experienced team of medical doctors, Nurses and Pharmacists.
  • SOPs developed as per ICH-GCP, FDA and other international guidelines
  • Independent quality assurance team for conducting online quality audits.
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Specifications

Categories Contract Services - Pre Clinical Trials, Clinical Trials Stages 1-4, CRO, Clinical DataBio Analytical Services; Contract Services - Bio ServicesBio Services; Contract Services - Bio Services
Sales markets Eastern Europe; Middle East; Asia; North America; Central/South America
Supplied from China; India; Korea, Democratic People's Republic of; Malaysia
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Bioequivalence Studies

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