Quality Assurance, Quality Control and Regulatory

The Neos Therapeutics on-site quality control laboratories provide all raw materials and product testing, including:

  • Stability
  • Microbiology
  • Method development/validation

The Neos laboratories feature:

  • HPLC
  • GC
  • Dissolution
  • FTIR
  • UV-VIS
  • Laser diffraction particle size
  • Microbial identification systems

The Neos quality assurance and regulatory affairs staff employs certified quality engineers and regulatory professionals with experience in compiling a variety of regulatory submissions (IND, NDA, 505(b)(2), ANDA).

Neos provides regulatory expertise in selecting product candidates for our proprietary drug delivery technology. We maximize market potential by choosing appropriate compounds and therapeutic areas that provide clinical benefits to patients.