About Us

AnaCipher CRO is managed by a group of dedicated professionals with over 15 years of experience in clinical research. At AnaCipher CRO, all operations are driven by GCP and GLP systems as well as applicable national and international regulations. AnaCipher CRO has over 200 SOPs for clinical, clinical lab, bioanalytical, biostatistics, pharmacokinetics and QA operations and more than 200 validated methods.

AnaCipher CRO has been involved in more than 500 bioequivalence and pharmacokinetic studies and first-in-human phase-I clinical trials AnaCipher CRO also has expertise in analytical work for new chemical entities (Phase I-III studies). Most of these studies have been carried out for international regulatory submissions include US FDA, UK MHRA, Thai FDA, WHO, Netherland and France and Chile ANAMED. AnaCipher CRO is authorized by the Drugs Controller General of India and has been inspected by the US FDA. Our clients have received product approval for generics in US and EU for which the biostudies were done at AnaCipher CRO.

Regulatory Approvals

Netherlands & France

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

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