Highlights of the 2024 CAPRA Symposium - #HealthCanada Updates on review decisions and nitrosamine impurities. https://lnkd.in/gYeV4Rkn
Regxia Inc.
Pharmaceutical Manufacturing
Toronto, Ontario 1,320 followers
Expert Regulatory Solutions
About us
Regxia is a unique scientific and regulatory consulting firm serving the pharmaceutical and biotech industries. At Regxia we strive to provide personalized attention focusing on your specific regulatory needs. We offer a full range of regulatory services to support your product at all stages of development, from concept to launch and throughout its lifecycle. We excel by taking a collaborative approach on every initiative, delivering high quality, customized solutions consistent with your corporate culture and the ever-evolving regulatory environment. Our in-depth awareness and understanding of global regulatory requirements allows us to outline appropriate regulatory strategies which minimize time to market. At Regxia we have one purpose: to ensure our clients’ success and we accomplish this by using the most innovative approaches in the industry. Regxia's team has the knowledge, experience and insight your business needs to achieve its regulatory objectives. Whether provided as part of overall project management or on a stand-alone basis, Regxia will advise on a full range of regulatory services including: scientific writing, strategic consulting, dossier publishing (eCTD), CMC, clinical, and post-approval support. Our clients are our primary focus. Proven Experience...Fresh Thinking! www.regxia.com info@regxia.com
- Website
-
https://www.regxia.com
External link for Regxia Inc.
- Industry
- Pharmaceutical Manufacturing
- Company size
- 11-50 employees
- Headquarters
- Toronto, Ontario
- Type
- Privately Held
- Founded
- 2007
- Specialties
- Regulatory Services, e-Submissions & Lifecycle Management, Dossier Compilation & Management, CMC, Scientific and Strategic Consulting, Nonclinical Development, Clinical Regulatory Strategy, Online GCP Training, QA System, Pharmacovigilance, and Audits & Inspections
Locations
-
Primary
Keele & Hwy 7
Toronto, Ontario L4K 3P3, CA
Employees at Regxia Inc.
Updates
-
Health Canada releases notice regarding mandatory filing requirements for XML PMs, starting in 2025. Are you ready for XML PMs? https://lnkd.in/eGth9wic
-
Health Canada’s updated guidance on drug submissions for biologic products combines three guidance documents into one. Read more here https://lnkd.in/g4Mdx4-F
Update: Health Canada’s Guidance on Drug Submissions for Biologics
regxia.com
-
Heading to Long Beach for #RAPS2024 ? Come by Booth 431 and see how we can assist you with bringing your product to market #regulatory #ePublishing www.regxia.com
-
Pharmacovigilance / Drug Safety - What is it? And why is it necessary? #GVP #Pharmacovigilance https://lnkd.in/gaiG6VJC
Pharmacovigilance / Drug Safety Defined
regxia.com
-
We're going to #RAPSConvergence! We hope to see you in Long Beach at the biggest event in regulatory affairs! Booth 431
-
Health Canada’s updated GUI-0119 helps companies understand and comply with GMP requirements for fabricating and packaging/labelling of sterile drugs. https://lnkd.in/gDhKAXkQ
Updates to Health Canada’s GUI-0119: Manufacture of Sterile Drugs
regxia.com
-
eCTD Publishing - Why outsourcing it is the right choice for small to mid-sized pharma. #eCTD #ePublishing #FDA #HealthCanada https://lnkd.in/gFMz3eFd
eCTD – Why Outsource?
regxia.com
-
Heading to San Diego for the #DIA2024? Come by booth 2326 and see how Regxia can assist you with preparing your product's #regulatory submissions http://regxia.com
-
Health Canada's XML PM: What is it? Why does it matter for Sponsors? What are the challenges? How can you prepare? https://lnkd.in/gYPvA2Gh #HealthCanada #HealthCanadaXMLPM #XMLPM #ProductMonograph
XML PM: What is it and why does it matter to sponsors?
regxia.com