Facility

    

Facility >> Bioanalytical

  1. Developed and validated above 200 bioanalytical methods
  2. Bioanalysis of generic molecules as well as new chemical entities (Phase I-III) and achiral assays
  3. Analytical equipment's include AB Sciex LC-MS/MS systems- API 4500, API 4000 and Shimadzu HPLC Systems as front end systems
  4. Equipped with sodium vapor lamps (analysis of light-sensitive drugs) and fume hoods in sample processing area
  5. Deep freezers (–700C and –200C) for sample storage
    1. Fitted with an alarm system for detecting temperature deviations
    2. Connected with on-line data monitoring system
    3. 21 CFR Part 11 compliant software

Click here for a list of validated methods.

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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