Following are the working models followed by DRK to ensure the availability of high-quality services on our end:
1. Lab-scale Product Development
- Formulation Optimization
- Exhibit scale ready formulation
- Analytical Method Development
2. End-to-end Product Development till Marketing Authorization Attainment
- Analytical Method Development
- Tech Transfer to the site of manufacturer or CMO
- Manufacture of exhibit scale, commercial scale batches
- Submission of eCTD dossier
3. Product Dossier Out-licensing
- Module 2 – Module 5 Dossier in ready-to-submit form is provided for submission to requisite Regulatory Authority
- Product Dossier Out-licensing & Commercial Supply of Finished Product
- Module 2 – Module 5 Dossier in ready-to-submit form is provided for submission to requisite Regulatory Authority and Commercial Supply of Finished Product to client’s desired site
- In-Licensing/Acquisition of Product Dossiers