Our comprehensive development activities includes:

• Intellectual Property Evaluation (IP related issues & Final IP clearance for drug substances (from attorney), Drug Product related IP landscape, Final IP clearance for drug product (from attorney)
• Literature search
• License application for Testing and Import of API and Reference Product.
• Designing Product development strategy, Figure of pre-formulation and formulation trials with scope for a patent-non-infringing formulation.
• Sourcing of API, Selection of API manufacturer ensuring the supply of patent-non-infringing drug substance of the good quality of production standards, and inspection of the facility by Qualified Person and a thorough evaluation of the Drug Master File.
• Sourcing of Excipient, packaging materials, columns and reference product
• Formulation Development approach based on QbD/DoE principles as per the USFDA/EMEA recommendations.
• Characterization of API and Reference Product
• Working standard qualification
• Analytical Method Development
• Analytical method development and validation for cleaning samples
• API-Excipient compatibility studies
• Prototype formulation development
• Packaging component selection
• Stability studies of prototype formulation.
• Photostability study.
• Formula finalization for scale-up and dossier submission batches / PV batches.
• Analytical Method validation
• Qualification and selection of finished product manufacturing sites for the technology transfer scale-up, and the first commercial launch opportunities.
• Technology Transfer Document Preparation and Submission to Client and CMO
• Analytical method transfer of finished product to the manufacturing site
• Execution of Scale-up and PV batches manufacturing Activities at the Manufacturing Site.
• Product development report
• Bioequivalence Study
• eCTD compilation
• Responding to regulatory queries to the license grant