Regxia is a regulatory consulting firm serving the pharma & biotech industries. Founded in 2007, Regxia is experienced in compiling and e-publishing compliant dossers for submission to the FDA and Health Canada. Regxia’s services also include conducting reviews of promotional and medical materials; XML PM creation; regulatory strategy; medical writing; and Canadian QA and PV activities.

Services:
Regulatory Affairs
Dossier Compilation & Management of Clinical & Marketing Applications (CTA, IND, NDS, ANDS, etc.)
eCTD & XML PM (preparation, management and publishing)
CMC
Canadian Quality and Pharmacovigilance Services