PRODUCT DEVELOPMENT

Nexgen offers a complete range of pharmaceutical formulation development services, analytical methods development, methods and process validation, suitability petitions, ANDA/NDA product submission, stability studies, raw material and finished product testing.

Our scientific staff (view scientific staff bios) draw from years of pharmaceutical and dietary supplement industry experience. Nexgen has the capabilities to take your product from development to commercial production.

We know that a timely and high quality response to your product needs is critical for your success in the marketplace. When it comes to challenging formulations and navigation of the regulatory landscape, Nexgen will be your partner throughout the development process.

Nexgen is proud to offer the following services to support your product development requirements:

  • · Formulation
  • · Solid dose delivery systems
  • · Methods development, refinement, & validation
  • · Active Pharmaceutical Ingredient testing
  • · Raw material testing
  • · Pilot/bio-batch manufacture
  • · Stability testing and storage
  • · Method and technology transfers
  • · Clinical supply manufacturing, packaging, and labeling
  • · Regulatory and technical management
  • · Regulatory assistance and monitoring
  • · Submission assembly and preparation
  • · FDA response preparation
  • · Commercial scale-up
  • · Process validation
  • · Cleaning validation

Nexgen specializes in providing clients a one stop, turn-key solution to product development, approval and commercialization.