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The MHICC is now Seriant !
The Montreal Health Innovations Coordinating Center (MHICC) is now Seriant.
Our new name reflects a bold step forward— expanding beyond cardiology and embracing innovations in clinical trials with a global reach.
While our identity has evolved, our commitment to operational excellence, client satisfaction, and quality remains the same.
Regulatory Affairs
Trust and Guidance in a Global Regulatory Landscape.
At Seriant, we provide comprehensive regulatory support to help companies accelerate approvals, ensure compliance, and mitigate risk at every stage.
We understand that selecting the right Clinical Research Organization (CRO) is essential for companies aiming to navigate complex regulatory landscapes and bring innovative therapies to market. In Seriant, you gain a trusted partner dedicated to delivering regulatory excellence and helping you achieve your development goals efficiently.
- End-to-end regulatory support
- Seamless integration with clinical development and project teams
- Accelerate approvals, mitigate risks, and ensure compliance
We provide strategic guidance on changing regulatory requirements across the globe, including regulatory agencies and Ethics Committees (IRBs/REBs):
- Expertise in FDA, EMA, MHRA, Health Canada, and more
- Understanding country-specific differences in submission & approval requirements, labeling, and compliance expectations
- Regulatory strategy development, to align study design with approval requirements
Our proactive approach ensures smoother approvals, minimizes regulatory hurdles, and accelerates timelines, helping clients navigate complex requirements with confidence.
- Experience across multiple therapeutic areas & global regions
- Risk-based regulatory strategies to anticipate challenges before submission, at country and site level
- Proven success in accelerating approvals & mitigating regulatory risk
We seamlessly integrate regulatory expertise into project workflows, ensuring efficient submissions, responsive query management, and on-time approvals.
- Integration with overall project planning, aggressive timelines
- Regulatory intelligence to align submissions with approval expectations
- Regulatory expertise embedded within project teams for proactive decision-making
- Strong & timely management of queries
- Site Support
We provide comprehensive support from initial strategies to post-trial requirements.
- Early strategy development, to align study design with approval requirements
- Lifecycle management, including change management, annual updates
- End of trial notifications & Clinical Study Report (CSR) submissions
Interested in this service?
Let’s work together!
