Drug Development Services
Mediviz offers drug product development services that leverage its formulation expertise and extensive process, analytical and manufacturing capabilities. Backed by rich expertise, disciplined and systematic approach to the hilt, Mediviz evaluates, analyzes, defines and refines the manufacturing process and procedures in adherence to QbD guidelines.
Mediviz assiduously develops the appropriate critical process parameter information and comprehensive drug product specifications. The information so obtained is packaged in technology transfer documents for submission to the Client/Contract Manufacturing Organization to scale up manufacturing activities.
Mediviz endeavors to provide comprehensive product development strategies meeting International standards, focusing on Regulatory and Management of Chemistry, Manufacturing and Controls (CMC) documentation generation, evaluating the appropriate Bio-equivalence study conducted at site in accordance to regulatory standards for conventional and specialized dosage forms.
Analytical testing methods are designed to meet clients’ exact specifications, while supporting rapid development time-lines and offering a spectrum of services like formulation and process development, development and validation of analytical methods, scale-up, process validation, and stability studies in accordance with the relevant guidelines (such as ICH).
Equipped to operate on stringent standards, Mediviz can fully and remarkably support your outsourcing needs from Formulation Development to Regulatory filing, guaranteeing quality, speed and value.
- Formulation Development
- Development & validation of Analytical Methods
- Scale-up, Process Validation & Stability Studies
- Arranging for Bio-equivalence Studies
- Dossier Filing as per the Market