With more than 15 years of experience, the Regulatory affairs is in charge
of the documentation required for registration of drug substances, clinical trials 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
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Galenix Pharma facilities
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