Services

AnaCipher CRO offers the complete range of studies including:

  1. Bioavailability
  2. Bioequivalence
  3. Pharmacokinetic
  4. Steady State Studies
  5. Food Effect Studies
  6. Single and Multiple Dose Studies
  7. Taste Evaluation Studies
  8. Phase I studies

Our services include:

  1. Study Design
  2. Protocol Preparation
  3. Subject Selection
  4. Clinical Lab
  5. Bioanalysis
  6. Pharmacokinetic Evaluation
  7. Statistical Data Evaluation
  8. Study Result Reporting
  9. Archiving

AnaCipher CRO has been involved in bioequivalence and pharmacokinetic studies carried out for national and international regulatory submissions including:

  1. USFDA
  2. UK-MHRA
  3. Thailand FDA
  4. DCGI
  5. Netherland and France
  6. Chile ANMED
  7. WHO
  8. Health Canada
  9. TGA Australia

Bioanalytical Services:

  1. Method development and validation
  2. Bioanalysis for generic drugs (BE studies)
  3. Bioanalysis for NCEs (Phase I-III studies)
  4. Sample storage

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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