- 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