Galenix Drug Delivery Solutions, Drug Product Development, Licencing-Out Opportunities

Regulatory Affairs

Regulatory affairs team is central to Galenix as It coordinates the numerous steps in developing new medical products within an appropriate regulatory framework

With more than 15 years of experience, the Regulatory affairs Department is in charge of the documentation required for registration of drug substances and drug products:

  • European and US DMF
  • IMPD, pre-IND meeting, IND, etc…
    Marketing Authorization Application C.T.D., ANDA, NDA, compiling and Submission on customer’s behalf or Galenix’s

The Regulatory affairs also Coordinates Phase I clinical studies in partnership with more than 10 C.R.O. in Europe and worldwide, bioanalysis and toxicology laboratories.