Bioequivalence Studies

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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Auriga Research Pvt Ltd

  • IN
  • 2018
    On CPHI since
View company profile
Categories
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Specifications
  • Supplied from
    China; India; Korea, Democratic People's Republic of; Malaysia
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Sales Markets
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Auriga Research Pvt Ltd

  • IN
  • 2018
    On CPHI since
View company profile

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    Auriga Research is a Proficient Bioequivalence and Analytical Partner for Pharmaceuticals, Neutraceuticals, Food and Herbal Industries serving best quality since 2007 in :

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Auriga Research Pvt Ltd resources (1)

  • Trusted partner for analytical and bioqeuivalence Studies

    Brochure Trusted partner for analytical and bioqeuivalence Studies

    Auriga Research is one of the leading Contract Research and Testing Organization (CRO) with 33 years of illustrious Industry experience, especially into analytical, Bio-analytical and Clinical services. Auriga boasts of 2 Clinical Units with 6 State-of-the-Art Laboratories with a dedicated team of more than 550 people redefining trust in the brand. Auriga has been instrumental in successfully submitting more than 175 Bio-equivalence Studies with global client base. Auriga has expertise in Bioequivalence Studies, Method Development and Validation, Stability Studies, and Formulation Development for Pharmaceutical Industries. Auriga is accredited and approved by DCGI, NABL, NPRA Malaysia, FSSAI, CDSCO ect.