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

Dosage forms & Processes

 
 

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.

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