Facility

Facility >> Medical Writing and Regulatory

  1. Well qualified and experienced medical writing team to comply with the requirements of national and international regulations.
  2. Development of Protocols, Investigation Brochures, Informed Consent Documents, Case Report Forms all other regulatory related documents.
  3. Experience in dossier preparation, submission, tracking of BENOC and Import licenses from DCGI and CDSCO.

Updates

   Indoco’s CRO - AnaCipher successfully completed USFDA audit (Clinical phase) with zero 483s for seventh consecutive time in September 2022
  AnaCipher CRO clears USFDA inspection with zero 483 in July 2022 for bioanalytical phase
   Indoco's Clinical Research Organisation – AnaCipher receives accreditation from UKMHRA
  AnaCipher CRO receives BE study approval from NPRA-Malaysia in July 2021, through a desk assessment review process. The review process involved all the phases of the study.
  AnaCipher CRO receives BE study approval from WHO in March 2020, through a desk assessment review process. The review process involved the Clinical & Bio-analytical phases of the study.
   Indoco's CRO – AnaCipher receives EIR from USFDA

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