• Regulatory News

    Regxia Inc.'s chosen e-Publishing software has been in use in our office for the past 10 years and we are happy to say that Health Canada and the FDA have both adopted the same system.

    Since first offering this service, Regxia has compiled, validated and submitted over 5000 e-submissions (base submissions and lifecycle sequences) to Health Canada and the US FDA. The recent migration of both agencies to the same e-software allows the reviewers to be capable and comfortable navigating our client’s submissions during review.

    We look forward to assisting more potential clients with their Regulatory and e-Publication needs.


  • Our Clients Speak

    Our Clients Speak

    “Our experience compiling an NDS with Regxia was extremely positive. The Regxia staff contributed meaningfully to our project at both the strategic and tactical levels. They handled the entire e-publishing aspect of the submission, and helped us achieve an extremely aggressive timeline. The staff are highly knowledgeable and very pleasant to work with. We commented several times during the process that if all our consultants were as competent as those at Regxia, our jobs would be very easy. Regxia staff acted with the same level of commitment as if they were employees of our company, and one can’t ask for more than that!”


  • Events and Presentations

    DIA Annual Meeting, Booth 823: June 14-18 Washington.

    Looking forward to another strong year at the DIA Annual Meeting. Visit us at Booth 823 and discuss how our one-on-one approach to your regulatory, clinical, and quality needs can guide you through clinical and marketing success.
    Looking forward to assisting more potential clients with their Regulatory, Clinical, and Quality needs at #DIA2020.


    Our Clients Speak

    “I want to take this moment to thank you for the great work you did in the preparation of the SNDS. In addition to the many hours you spent preparing the dossier, I know you have worked all weekend to ensure an earlier submission. One more example of the commitment to excellence you and your team have demonstrated over the last 17 years. Thank you again for your continuous support.”


  • New Refined Look, Same Respected Regxia

    proven experience...
    fresh thinking


    Our Clients Speak

    “Regxia has our heartfelt appreciation and sincere thanks for their effort and achievement in filing our submission. This speaks to your effort, the imprint you left in the agency meeting, and your ability to develop this filing with excellence and to deliver it in the shortest time-frame possible ensuring patients have access to this important drug as soon as possible.”


  • Regxia has Moved!

    Regxia has moved its head office to a new location, 64 Jardin Drive Unit 1C Vaughan, Ontario

    This new central location will allow the Regxia Team to grow in an environment that reflects Regxia's collaborative and modern approach to Regulatory Affairs.



    Serious Professional Development

    At Regxia we offer a rigorous employee training and mentoring program. Regxia strives to provides each new employee time to become familiar with each of our service areas and have all of their questions answered during their training and job shadowing with real world problems.


  • Events and Presentations

    RAPS 2019, Booth 410: September 21-24, Philadelphia.

    We are excited to announce that we will be exhibiting with RAPS for the 12th time. As a Canadian firm it is exciting to assist our Global clients with their FDA and Health Canada regulatory needs. We wish to welcome you to Booth 410 to discuss your Regulatory Strategy, outsourcing and e-Submission needs. Regxia is fully equiped to assist you in filing within the Canadian and US markets.


    Our Clients Speak

    “Our company has relied on the expertise and professionalism of the Regxia team for several projects both large and small over the years. In each case the quality of work and the value of their input has far exceeded expectations. I highly recommend the Regxia team.” — Director, Regulatory Affairs International Pharmaceutical Company


  • Regxia Inducted into prestigious 5k Club

    September 2017, Regxia was inducted into the Lorenz Life Sciences Group's 5K Club.

    This honour is bestowed to companies who have achieved the milestone of submitting over 5000 compliant e-submissions.


    Our Clients Speak

    “I just wanted to say thank you very much for all of your help with getting our application prepared and submitted, and also with responding to the Agency's information requests since that time. A lot of work went into both the preparation and publication of these submissions, and we really appreciate Regxia's expertise and flexibility, expediting submission preparation where needed.”


  • New Refined Look, Same Respected Regxia

    proven experience...
    fresh thinking


    Regxia's Quality Advantage

    Regxia has implemented a highly effective quality system to ensure all projects are completed accurately and efficiently. Checkpoints are integrated into all stages of a project, ensuring that errors are detected early and that quality is built-in. Regxia's quality advantage enhances our commitment to deliver the best possible product to our client!


  • Regulatory News

    Regxia Inc.'s chosen e-Publishing software has been in use in our office for the past 10 years and we are happy to say that Health Canada and the FDA have both adopted the same system.

    Since first offering this service, Regxia has compiled, validated and submitted over 5000 e-submissions (base submissions and lifecycle sequences) to Health Canada and the US FDA. The recent migration of both agencies to the same e-software allows the reviewers to be capable and comfortable navigating our client’s submissions during review.

    We look forward to assisting more potential clients with their Regulatory and e-Publication needs.


  • Our Clients Speak

    Our Clients Speak

    “Our experience compiling an NDS with Regxia was extremely positive. The Regxia staff contributed meaningfully to our project at both the strategic and tactical levels. They handled the entire e-publishing aspect of the submission, and helped us achieve an extremely aggressive timeline. The staff are highly knowledgeable and very pleasant to work with. We commented several times during the process that if all our consultants were as competent as those at Regxia, our jobs would be very easy. Regxia staff acted with the same level of commitment as if they were employees of our company, and one can’t ask for more than that!”


  • Events and Presentations

    DIA Annual Meeting, Booth 823: June 14-18 Washington.

    Looking forward to another strong year at the DIA Annual Meeting. Visit us at Booth 823 and discuss how our one-on-one approach to your regulatory, clinical, and quality needs can guide you through clinical and marketing success.
    Looking forward to assisting more potential clients with their Regulatory, Clinical, and Quality needs at #DIA2020.


    Our Clients Speak

    Our Clients Speak

    “I want to take this moment to thank you for the great work you did in the preparation of the SNDS. In addition to the many hours you spent preparing the dossier, I know you have worked all weekend to ensure an earlier submission. One more example of the commitment to excellence you and your team have demonstrated over the last 17 years. Thank you again for your continuous support.”


  • New Refined Look, Same Respected Regxia

    proven experience...
    fresh thinking


    Our Clients Speak

    “Regxia has our heartfelt appreciation and sincere thanks for their effort and achievement in filing our submission. This speaks to your effort, the imprint you left in the agency meeting, and your ability to develop this filing with excellence and to deliver it in the shortest time-frame possible ensuring patients have access to this important drug as soon as possible.”


  • Regxia has Moved!

    Regxia has moved its head office to a new location, 64 Jardin Drive Unit 1C Vaughan, Ontario

    This new central location will allow the Regxia Team to grow in an environment that reflects Regxia's collaborative and modern approach to Regulatory Affairs.



    Serious Professional Development

    At Regxia we offer a rigorous employee training and mentoring program. Regxia strives to provides each new employee time to become familiar with each of our service areas and have all of their questions answered during their training and job shadowing.


  • Events and Presentations

    RAPS 2019, Booth 410: September 21-24, Philadelphia.

    We are excited to announce that we will be exhibiting with RAPS for the 12th time. As a Canadian firm it is exciting to assist our Global clients with their FDA and Health Canada regulatory needs. We wish to welcome you to Booth 410 to discuss your Regulatory Strategy, outsourcing and e-Submission needs. Regxia is fully equiped to assist you in filing within the Canadian and US markets.


    Our Clients Speak

    “Our company has relied on the expertise and professionalism of the Regxia team for several projects both large and small over the years. In each case the quality of work and the value of their input has far exceeded expectations. I highly recommend the Regxia team.” — Director, Regulatory Affairs International Pharmaceutical Company


  • Regxia Inducted into prestigious 5k Club

    September 2017, Regxia was inducted into the Lorenz Life Sciences Group's 5K Club .

    This honour is bestowed to companies who have achieved the milestone of submitting over 5000 compliant e-submissions.


    Our Clients Speak

    “I just wanted to say thank you very much for all of your help with getting our application prepared and submitted, and also with responding to the Agency's information requests since that time. A lot of work went into both the preparation and publication of these submissions, and we really appreciate Regxia's expertise and flexibility, expediting submission preparation where needed.”


  • New Refined Look, Same Respected Regxia

    proven experience...
    fresh thinking


    Regxia's Quality Advantage

    Regxia has implemented a highly effective quality system to ensure all projects are completed accurately and efficiently. Checkpoints are integrated into all stages of a project, ensuring that errors are detected early and that quality is built-in. Regxia's quality advantage enhances our commitment to deliver the best possible product to our client!




About Regxia

Regxia is a unique scientific and regulatory consulting firm serving the pharmaceutical and biotech industries. The client is our primary focus. We take a collaborative approach on every initiative, delivering high quality, customized solutions consistent with your corporate culture and the ever-evolving regulatory environment. Read more

Regulatory
  • e-Submissions
  • Pharmaceuticals
  • Biologics
  • Orphan designation
  • Generics
Clinical
  • Support
  • Monitoring
  • Management
  • Audit & Inspection

Learn@Regxia
  • GCP Training
  •  

Quality
  • QA System Development
  • Safety Reporting
  • SOPs
  • Audit & Inspection