Conducting Third Party Onsite and remote audits of manufacturing sites engaged in:

• Development and manufacturing of Pharmaceutical Finished formulations (for clinical trial and saleable small & large batch scale finished products) – Oral solids, Parenteral, Topical, Transdermal and Liquids at CMO/CDMO sites.
  Compliance with required standards:US FDA 21 CFR Parts 210 and 211, EudrLex Vol. IV part I, PIC/s, WHO GMP, Schedule M and other regional country specific regulatory guidance.


• Manufacturing of Biologics including Vaccines and Mabs.
  Compliance with required standards:WHO GMP, 21 CFR part 600


• Labelling, walleting and repackaging sites of drug products intended for clinical trial studies including the cold chain temperature control
  Compliance with required standards:PIC/s, country specific GMDP guidelines


• Development and manufacturing of Active pharmaceutical ingredients (for clinical trials and commercial use) produced synthetically and or fermentation process and their associated intermediates and chemicals and key starting materials.
  Compliance with required standards:ICH Q7, EudraLex Vol. IV part II


• Manufacturing of excipients (animal, chemical and plant-derived)
  Compliance with required standards:WHO TRS 1052, IPEC


• Medical devices, Primary and Printed secondarypackaging materials
  Compliance with required standards:WHO TRS 901, ISO 13485, ISO 15378


• Dosing of drug product under clinical trials v/s the comparator drug product to volunteers at CROs.
  Compliance with required standards:Client specific clinical study protocols