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Regulatory Support

Delivering the best regulatory compliant products :
Beyond manufacturing, we stand by our clients and simply their compliance measures. Having had long experience of delivering solution that meets various regulatory requirements, including 17 Products haveing USDMF registration, we are adept to deliver the following regulatory support

  • Stability Data as per ICH Guidelines
  • Residual Solvent as per ICH Guidelines
  • Technical Data Package in CTD format for all products
  • Declarations available as per Global Regulations
  • Specs, MOA and MSDS as per current Global Standards
  • Preset VAQ for all customers as per Global Standards for better customer service
  • Documentations as per the ICH/IPEC guidelines
  • Drug Master File ( For Our Record)

Our Quality ensures our products are free of :

  • Residual Solvent as per ICH guidelines
  • Genetically Modified Organism
  • Allergens
  • Gluten Free
  • Melamine Free
  • Dioxin, Aflatoxin
  • Genotoxic Impurities
  • Metal Impurities (Less than 5 ppm)

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