Expertise

  • Well versed with FDA for communicating regulatory topics.
  • 90 % success rate in pilot & pivotal BE
  • Patent driven like landscape & evaluation of Product / Process / MOU / FDF patents
  • Infringement analysis, polymorph selection, attorney opinions and supporting for litigations
  • QA handles stability loading/unloading, RLD distribution & its stability loading/unloading
  • cGMP manufacturing of pilot BE batches
  • BE & CT strategy support
  • Engaged with multiple CMOs for manufacturing exhibit & commercial batches in India, EU, UK,Asia.
  • Chromatograhy and Non-Chromatography servers with back-up