Following are the working models followed by DRK to ensure the availability of high quality services on our end:
I. Lab-scale Product Development
Formulation Optimization
Exhibit scale ready formulation
Analytical Method Development
- 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
- 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
