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PRODUCT DEVELOPMENT

FORMULATION DEVELOPMENT» ANALYTICAL DEVELOPMENT» Quality assurance»

 

Product development at Rubicon begins with Patent Landscaping and Strategy Development. Desired product attributes are identified and prototype formulations are developed to meet the desired product attributes. Critical process parameters are identified and process optimization studies are carried out. Based on the formula and process optimization studies, final composition and manufacturing process is recommended for bio-study and scale-up.

Rubicon offers formulation development services across diverse dosage forms such as oral solids, oral liquids, disperse systems, ophthalmic drug products, parenterals and nasal systems.

Rubicon offers instant resource deployment for stand-alone analytical services. We have a team of chemists and senior scientists, product experts, quality testing services and a robust project management and communication systems to ensure highest quality analytical services.

Rubicon’s analytical services department has more than 100 scientists across the two locations and services include

  • API Characterization
  • Analytical Method Development
  • Analytical Method Validation
  • Microbiological Testing

Quality Assurance at Rubicon is undertaken at both the sites independently. Quality Assurance is a governing part of drug development. At Rubicon we strictly follow Standard Operating Procedures for establishing quality assurance practices, such as preparation, maintenance, definition, classification and change Control of Quality and Master file documentation; recording and reporting procedure for deviations management; quality concern investigation Process; customer complaint handling procedure; quality audit procedures; vendor assessment, evaluation and certification procedure; rework procedures for the defective manufactured products; procedures on training and many others.