| Credentials
WeÕre certified
Baralex represents many of the world's leading manufacturers and abides strictly by their governance of ethical standards and procedures. We also adhere to the Good Manufacturing Practices Guidelines (cGMP) and to the International Conference on Harmonisation of Technical Requirements of Pharmaceuticals for human use (ICH). Baralex fully complies with all government regulations related to health, safety, and the environment. We are a member of the Custom-Trade Partnership against Terrorism(C-TPAT).
Our 8,000 square foot facility in Montreal, Canada is fully licensed to receive and store precursors and narcotics.
We cut through red tape
Our professionals have the expertise (and an uncommon passion for
paperwork) required to successfully navigate international regulatory
environments. If your project requires a Common Technical
Document (CTD), Drug Master File (DMF), or a Mutual Recognition
Agreement (MRA), we also have the know-how to help expedite the process.
In addition, our experts can ensure that all necessary import/export documents have been obtained, to make sure that your orders sail across international borders with a minimum of fuss.
Drug master file products
From FDA approved manufacturers, we can supply a wide selection of raw material drug master files (DMF's) for molecules that have come off patent or soon will.
Contact us today for more information about these exciting opportunities.
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