laboratory1

Formulation Development

  • Excipient compatibility
  • Formulation troubleshooting and Process Development of existing dosage forms
  • Development and Optimization of existing formulations
  • Quantitative and Qualitative evaluation of proprietary dosage forms
    • Tablets [Uncoated/Film Coated/Enteric coated/Sugar coated/Effervescent]
    • Capsules [Starting from Size 0 to Size 4 Caps]
    • Oral Liquids [Syrup/Suspension]
    • Ointments [Ointment/Cream/Gel]
    • Nasal Sprays [Spray/Drops, Clear/Suspension]

Infrastructure Support

  • Separate Dedicated Area for Raw Material under Lock and key
  • Separate AHU system in each area of F and D.
  • Under development plan for new Dedicated Facility of Aerosol/MDI products
  • Under development Facility for Immediate release mouth Tablets [ by Lyophilisation]

Analytical Development

Analytical development is a vital component of our R&D agenda with special focus given to:

  • Analytical Method Development for Assay, Dissolution and Related Substances
  • Testing of API and Excipients as per Pharmacopeia and by In House Method
  • Method Validation – for Assay, Dissolution and Related Substances
  • Stability Studies as per ICH Guidelines
  • Process Validation and Packing Validation
  • Comparative Study with Innovator for various parameters as per Pharmacopeia and by In House Method
  • Dissolution Testing
  • Documentation for audit trail

Regulatory Affairs

In today’s competitive environment the reduction of time taken to reach the market is critical to a product’s and hence the company’s success. Our Regulatory Affairs team keeps track of the ever-changing legislation in all the regions in which the company intends to market its products.

‘Right First Time’ approach of our Regulatory Affairs plays a crucial role in coordinating scientific endeavour with regulatory demands throughout the life of the product, helping to maximize the cost-effective use of the company’s resources. It also advises on the legal and scientific restraints and requirements, collect and evaluate the scientific data generated by R&D. Our Regulatory Affairs is capable of all types of regulatory submissions (Dossiers / ANDA / ANDS / CTD / e CTD) to any of the semi-regulated to highly regulated markets ensuring fast turn around in business.