Dossier Development for OSD forms

 

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Dossier Development

  • Formulation Development and line extensions to existing products

  • Design and execution of formulation trials

  • Development of Analytical Methods and Validation

  • Strategy and execution of product scale up, transfer and validation

  • Support for Clinical (BE) studies

  • Regulatory Strategy and Dossier Compilation

  • Launch & Commercial Supply Services through our exclusive manufacturing partners  

 
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OSD Technologies

  • Dry mixing

  • Wet granulation (aqueous and solvent)

  • Dry granulation (roller compaction)

  • Pellets by layering, MUPS

  • Mono and Bi-layer tableting

  • Encapsulation (powder, pellets, mini/micro tablets)

  • Cosmetic and Functional (IR, API and MR) coating

  • Specific expertise on complex coating processes for multi-layered pellets and tablets

Product Dossiers therapeutical categories

ANTITHROMBOTIC AGENTS
CARDIOVASCULAR
ANTIVIRAL
ANTIBACTERIALS FOR SYSTEMIC USE
INTESTINAL ANTI INFLAMMATORY AGENTS
IMMUNOSUPPRESSANTS (MS)
HEMOSTATICS

For more information about the products dossiers in each category and their status, please contact us.