Regxia
Information
Regxia is a unique regulatory and e-publishing consulting firm serving the pharma & biotech industries. We prepare, e-publish, and submit clinical and marketing applications and lifecycle sequences to the FDA and Health Canada. Founded in 2007 we have experience handling products across their full lifecycle.
Regxia acts as an extension of our clients RA and QA operations, conducting promotional and medical materials reviews, NDA/NDS, IND/CTA, eCTD publishing; XML PM publishing for Canada; CMC; medical writing; and Canadian QA and PV activities.
Products and Services
- Regulatory and Quality Consulting
- Electronic Submissions & XML PM
- Regulatory Affairs/Regulatory Strategy
- Regulatory CMC
- Regulatory Document Preparation
- SRTD Search & M2.4, 2.5 Preparation
- DEL Applications & Management
- Health Canada GMP Inspection Support
- Ongoing QA Compliance - investigations and deviations, releases, coordination of testing, TQA reviews, APQR review/preparation
- Advertising and Promotion Compliance
- Drug Safety / Pharmacovigilance