CLINICAL SUPPLIES

meet us at
Oct. 25th - 27th - 2011
CPHI Frankfurt - Germany
March 12th - 15th - 2012
DCAT New York - USA

LAST NEWS
2011 - Certificate of GMP compliance of a Manufacturer for Human investigational medicinal product

2011 - Certificate of GMP compliance of a Manufacturer for Human medicinal product

MAA CESSION & TRANSFER
Licensing-out opportunity Cetirizine 10 mg/ml, oral solution (NL33352)
NEW MAA CESSION & TRANSFER
Licensing-out opportunity Donepezil 5 mg, ODT (NL37771) and Donepezil 10 mg, ODT (NL37772)
2009 - cGMP Agreement for human use

Galenix Pharma has obtained an updated agreement for cGMP manufacturing, importation and ditribution of human and investigational medicinal products AFSSAPS #M09/168
2008 - cGMP Agreement for veterinary use

Galenix Pharma has obtained an agreement for cGMP manufacturing, importation and distribution of veterinary and investigational medicinal products AFSSA #V1515/08
MAA CESSION & TRANSFER
Licensing-out opportunity Fenofibrate 67 mg, tablet (NL27271) - Fenofibrate 200 mg, tablet (NL27274) and Fenofibrate 160 mg, modified release tablet (NL31360)

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Galenix is a pharmaceutical company offering a comprehensive clinical service in compliance with international cGMP environment (cGMP Europe & US FDA) from the manufacturing through the clinical packaging, the distribution to the registration submission.

Galenix' team supports all your clinical supply needs from Phase I to Phase IV.
Our cGMP manufacturing facilities are fully compliant with Europe and US FDA requirement authorities.


Our clinical trial manufacturing (CTM) and packaging services includes :

  • US, Europe and other regulatory standards.
  • Phase I, II, III, IV clinical and pilot supplies.
  • Full clinical manufacturing, packaging and quality control testing.
  • Pre-IND, IND, IMPD and CTD support documentation.
  • QP release for use in Europe.
  • Importation cGMP authorization.
  • Full quality support for clinical supplies.
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