Generic Parenteral Product Development 2020-01-08T19:43:54+00:00
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Generic Parenteral Product Development

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
  • Scale-up
  • 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.

So there’s no need to manage multiple CMOs — eliminating tech-transfer delays, streamlining processes and enabling you to meet your filing timelines.