Experience in formulation and development of solid oral dosage forms in regulatory markets.
Conducting literature and patent searches for assigned projects, with familiarity in regulatory guidelines.
Preparing applications for Form 29, Form 11, RLD import licenses, Form 25, etc.
Procuring raw materials (API/Excipients), packing materials, and innovator samples in consultation with packaging, regulatory, and purchase departments.
Executing pre-formulation and formulation optimization trials using a Quality by Design (QbD) approach to develop robust formulations.
Manufacturing batches for stability studies and performing other studies on optimized formulations.