Formulation Development​ Services

​Formulation development services cover the wide development spectrum from early safety studies to toxicity studies; proof of concept formulation development and late stage formulation development, to dosage manufacturing, packaging, and development for product life cycle management extension. Packaging and storage conditions are suggested based on thorough stability studies.

  • Proof-of Concept formulation development for early stage decisions

  • Initial formulation design and screening leading to lead prototype (composition and processes) identification

  • Reverse engineering of the Reference Listed Product

  • DOE - Design of Experiment

  • Prototype development as per QBD

  • Quality Target Product Profile - QTPP

  • Formulation Composition Optimisation

  • Process Development

  • Impurity profiling for active in drug product

  • Choosing suitable manufacturing process

  • Scale-up of prototype with batch records

  • Process parameters optimisation for manufacturing process using QbD approaches

  • Manufacturing supervisions of batches for stress stability (ICH conditions)

  • Scale-up of batches supervision and technology transfer

  • Formulation validation and supervision