Regxia Inc.
Regxia is a unique regulatory and e-publishing consulting firm serving the pharmaceutical and biotech industries.
For 17 years, we have acted as an extension of our clients' RA and QA operations, conducing promotional and medical materials reviews, NDA/NDS & IND/CTA preparation, eCTD publishing; XML PM publishing for Canada; CMC; medical writing; and Canadian QA and PV activities.
Services: FDA, Health Canada, - Dossier & eCTD (compilation-management-publishing); CTAs-IND, NDA, ANDA, etc.; Promotional and Medical Reviews; XML PM; surrogate Canadian QA department and PV support.
Regxia is a unique regulatory and e-publishing consulting firm serving the pharmaceutical and biotech industries.
For 17 years, we have acted as an extension of our clients' RA and QA operations, conducing promotional and medical materials reviews, NDA/NDS & IND/CTA preparation, eCTD publishing; XML PM publishing for Canada; CMC; medical writing; and Canadian QA and PV activities.
Services: FDA, Health Canada, - Dossier & eCTD (compilation-management-publishing); CTAs-IND, NDA, ANDA, etc.; Promotional and Medical Reviews; XML PM; surrogate Canadian QA department and PV support.
Products (2/6)
Regxia provides outsourced regulatory affairs support for FDA and Health Canada applications. We utilize our experience and knowledge of regulatory requirements to outline an appropriate regulatory strategy and prepare your dossier to minimize your product's time to market.
Regxia offers strategic and innovative regulatory advice throughout the entire development process.
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