Research And Development

Formulation And Analytical Development

The formulation development Experts of Pharma Quality Setters are capable of innovative and generic formulation development of products of different dosage forms and therapeutic categories. The different stages of formulation development activities are carried out as per customers requirement.

  • R & D Conceptual Design
  • R & D Lay Out
  • Equipment List
  • Qualification and Re qualifications of Equipment
  • Qualified and Experienced R & D Staff Recruitment
  • Delegation of Authority
  • Job Description of Each stage
  • Training to all Staff

Formulation Development Stages

  • Detailed literature search and preliminary patent search
  • Prototype formulation development
  • Innovator product characterization
  • Pre formulation studies
  • Formula and process optimization studies
  • In-vitro release study for semisolids
  • Stability studies of lab scale batches, as per ICH Guidelines
  • Technology transfer dossier
  • Manufacture of Scale-up and Exhibit batches
  • Troubleshooting for developed products

Analytical Development Stages

  • Lay Out Design
  • Set Up Of Quality Control Lab
  • Quality Control Equipment List
  • Qualification and Re Qualification Of Quality Control Equipment
  • Lab scale stability studies
  • Analytical Method Development
  • Analytical Method Validation Studies
  • Assay Development
  • Chemical & Chromatographic Analysis (LC/GC) for development report
  • Dissolution Testing
  • Forced Degradation Studies
  • In Vitro Testing
  • Photo stability
  • Stability Studies as per ICH for development report
  • Vitamin Analysis
  • Water Testing (Chemical)
  • Wet Chemical Analysis
  • Impurity Profiling
  • Residual Solvent Analysis
  • Stability Indicating Method Development & Validation
  • Moisture Uptake Studies