Generic Parenteral Product Development
LSNE can help you get your generic product to market quicker, with a full array of in-house formulation development services and a real-world understanding of every stage of development — from reverse-engineering of branded products to preparing your final regulatory dossier.
- Analytical method development/transfer
- Process development
- Registration batches/PV batches
- ICH Stability
- Access to Type V DMF reviewed and approved by the FDA
- Regulatory writing
We can work independently or lead a well-coordinated and experienced team to take on projects of any size. You get the ease and reassurance of partnering with a single vendor who has a comprehensive formulation development offering and extensive formulation and lyophilization expertise — as well as a dedicated Project Manager to oversee the process for you every step of the way.