Generic New Product Development Process
Our extensive process development and analytical experience is a great fit for your generic new product development process. We can work with you to reverse engineer branded products, validate all necessary analytical methods, and support your regulatory submissions. Our flexibility and rapid turnaround times will expedite your timelines and accelerate your goal to be the first to file.
Reverse Engineering of Branded Products
LSNE can work with you and execute a comprehensive experimental plan to develop a full portfolio for your generic submission. We understand that the timing of your filing is critical to your success and we’ve streamlined our generic new product development process through the years to allow you to file faster. You will get the peace-of-mind and reassurance of partnering with a single vendor who has the depth for all the development and sterile manufacturing expertise needed. LSNE can help get your generic product to market quicker, with a full array of in-house development, cGMP manufacturing and analytical services.
Efficient Scale Up
We have the experience and know-how to take the process from the bench to GMP with a seamless technology transfer process to take your product commercial:
- Strong customer-focused project management for generic new product development process
- Analytical method development and phase appropriate method validation
- Establish key material specifications for all raw materials and components
- Develop Master Batch Records and finished product specifications
- Development/machinability experiments
- Perform formulation/mixing studies to ensure homogeneity
- Filling studies to evaluate optimal filling parameters specifically for your product
- Develop visual inspection specifications
- Engineering runs and GMP clinical manufacturing
- Registration batches and supporting stability
- Regulatory support including CMC writing or access to Type V DMF
- Risk assessments and process characterization for commercial readiness
- Process validation and supporting stability
Regulatory Support for Generic New Product Development Process
LSNE can assist with all of your needs including regulatory writing or providing you with access to our Type V Drug Master File. We can provide supporting documentation or write full CMC sections, draft agency responses on challenging chemistry or analytical questions, and deliver custom support for clients, based on specific needs.
We utilize the FDA’s guidance and industry best practices to plan and execute your registration batches. First, we will set the product down on stability to start the clock for your stability time point testing to support your regulatory submission in the most expeditious way possible.