Formulation, Analytical development, and Stability
We support your analytical and product development needs through our associate company Uranus Laboratories and Genesis Biotech Pvt. Ltd. is engaged in Product development / Analytical method Development / Validation and Stability services for:
Product Development
- Total development of product from lab scale to pilot plant scale to actual production scale. This service includes Oral Solid Dosage Oral Liquid, small volume, Injectable, pellets, for General/Onco/steroids.
- Support in process optimization
- Technology Transfer of process and analytical methods
- Analytical Method development and validation
- Microbiological method development and validation
- Total Product characterization, Impurity profiling, Stability studies
- Investigation for product quality failure for critical quality attributes and suggest process modification accordingly
- Studies of nitrosamine impurity management, elemental impurities management
- A step-wise and strategic planning and development of process and successful technology transfer includes:
Initiation and Transfer
- Program initiation
- Cleaning validation
- Methods of transfer or development
- Process transfer
- Raw materials procurement
Development
- Small-scale CTM to support BE studies
- Scale-up to Commercial batch size
- Registration lots
- Scale-up
Filing and Commercialization
- Launch Planning
- Validation lots
- Scale manufacturing
- Regulatory filing support
