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Regxia, Inc.
About US:

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.

Web Site: www.regxia.com
Address:

1C – 64 Jardin Drive
Vaughan, ON  L4K 3P3
Canada

Contact:

Cameron McGregor
General Manager

Phone: 416-620-5236
Fax: 416-620-0261
Email: mcgregor@regxia.com

Geographic Areas: Canada
United States
Business Type: Consulting
Authorized Representative
Quality Assurance
Publisher
Products: Biologics
Combination Products
Drugs 
Patent Drug/New Drug/Brand Name Drugs
Generic Drugs
Orphan Drugs
Pharmaceuticals
Professional Responsibility (Regulatory Process): Submission/Registrations
eCTD – ePublishing
Biological License Approval (BLA)
Investigational New Drug (IND)/Clinical Trial Application (CTA)
New Drug Approval/Submission (NDA/NDS)
Premarket Approval (PMA)
Premarket Notification (510k)
Registration Establishment (DEL)