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

  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
   Indoco's Clinical Research Organisation receives zero 483s from USFDA
   Indoco's CRO – ANACIPHER clears USFDA inspection with ZERO 483
  Conducted internal training on “21 CFR Part 11” on 19th Jul 2019.
  Conducted external training on “ICH-GCP” on 29th Jul 2019

Enquiry