Formulation Development is the core activity at Zenvision Pharma and it includes Pre-formulation studies, formulation development, analytical method development & validation, stability studies, Dossier preparation & Technology Transfer. Formulation Development is based on QbD/DoE principles as per the USFDA/EMEA expectations.

 

Dosage forms & Processes

  • Tablet and Capsule Formulations; IR, SR, ER etc.
  • Mini & Bilayer Tablets
  • Fast Oral Disintegrating Tablet & Strips
  • Matrix & Coating Formulations
  • Topical including Cream, Gel, Lotion, Ointment, Otic & Ophthalmic Formulations
  • Oral liquid formulations -Suspensions, Syrups
  • Injectable including Lyophilized products
  • High Potency molecules

Zenvision has in-house state of the art formulation, analytical development & well supported by regulatory services, intellectual property management, quality assurance, clinical (BA/BE studies) & project management. Zenvision Pharma offers full support from concept to the commercialisation.

 

Pre-Formulation Studies

Zenvision engaged to perform Pre-formulation studies having core expertise with end-to-end profiling of molecules.

 

Formulation Development

Our advantage is based on offering IP and Regulatory compliant process proposals and approvals by the client for individual’s regions of interest. Our process involves Quality-By-Design (QbD) concepts at all stages of formulation development. The Design of Experiments (DOE) along with relevant time scale and risk assessment helps us to develop the strategy for further experimentation.

 

Product development is done in compliance with the latest regulatory guidance’s such as ICH Q8, ICH Q9, ICH Q10, QBD
Quality Target Profile (QTP), Critical Quality Attributes (CQA) & Risk assessment are integral part of development
Design of Experiments (DOE) is applied
Patent non-infringing formulation strategy
Proof of concept studies and create a position by proactively patenting technologies thus developed
Early protection to formulation opportunities
Efficient Project management
Creates Value by Innovation