R&D Center and Innovationr&d manufacturing sites

Regulatory Expertise

I’s Dotted, T’s Crossed

During the development of a product, Unither Pharmaceuticals provides the data for IMPD, NDA, ANDA, OTC monograph drug products dossiers, Medical Device conception and manufacturing dossiers.

Unither’s regulatory experts compile the registration dossiers (Product Quality Part) related to the operations performed by our technical experts:

  • Formulation
  • Process development and validation
  • Analytical development and validation
  • ICH stability studies.