Formulation development Specialties

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).

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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