Formulation Development Flow

Formulation development is Fusion’s core competency and we carry out development of 505 (b)(2), generic , novel, nutraceuticals, medical foods and over-the-counter (OTC) formulations with desired Critical Quality Attributes (CQA).

Product development begins with

Product development strategy including patent evaluation
Identifying and Establishing Desired product attributes and development of formulation
around the desired product attributes.
Prototype formulations with stability studies
Establishing Critical process parameters (CPP)
Formula and Process optimization based on Quality by Design (QbD) principles.
Final composition and manufacturing process recommended for bio study and scale-up.
Technology transfer to CMO