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Regxia is an established regulatory consulting and e-publishing firm supporting our client’s activities in the US and Canada for over 14 years. Regxia can prepare, adapt, e-publish, and submit your clinical and marketing applications to the FDA and Health Canada. Our services include dossier compilation & management of CTA / IND, NDA / NDS, SRTD, abbreviated submissions (ANDA/ANDS); lifecycle management and annual notification submissions, stand-a-lone eCTD publishing; CMC; medical writing; and regulatory strategy.
Additionally, Regxia's Canadian operations include boutique QA services for our clients' Canadian import and distribution activities. Our team can lead the procurement of an establishment license (DEL), handle Health Canada Inspections, prepare SOPs, and perform ongoing surrogate QA activities - acting as our clients Canadian QA team.
1C – 64 Jardin Drive
Vaughan, ON L4K 3P3