Regulatory Solutions
We provide end-to-end regulatory affairs and clinical development support to help our partners navigate the Health Canada landscape with confidence and efficiency. Our team offers strategic guidance from early development through life-cycle management, including regulatory pathway assessment, clinical trial applications (CTA preparation, management, and Health Canada interactions), and new drug submissions (NDS preparation and review). We ensure that clinical, medical, and commercial strategies are fully aligned with regulatory expectations, enabling faster, smoother progression from development to market. Whether designing and supporting clinical trials, managing labeling and lifecycle activities, or facilitating regulatory meetings, TIVMEK delivers the expertise, precision, and connectivity needed to facilitate approvals and ensure market readiness.
Regulatory Strategy Development
Develop tailored regulatory strategies that align with product attributes, therapeutic area, and business objectives. TIVMEK helps anticipate potential hurdles early, define optimal regulatory pathways, and determine the most efficient submission sequence and evidence package. We also provide guidance on Health Canada interactions, labeling considerations, and international alignment to ensure a cohesive and compliant approach from development through approval.
Submission Management
Oversee the complete preparation, compilation, and submission of regulatory applications — including NDS, ANDS, SNDS, and CTA filings — in accordance with Health Canada’s requirements. TIVMEK ensures that dossiers are scientifically sound, well-organized, and compliant with current regulatory guidance. Our team coordinates cross-functional input, manages timelines, and addresses Health Canada queries efficiently to help facilitate review and approval timelines.
Labeling and Product Monograph Development
Prepare, review, and optimize all labeling components — including Product Monographs, inner/outer labels, and packaging mock-ups — in full alignment with Health Canada and Plain Language Labelling (PLL) requirements. TIVMEK ensures scientific accuracy, regulatory compliance, and clarity for both healthcare professionals and patients. Our team also supports translation consistency, safety updates, and change control to maintain labeling integrity throughout the product lifecycle.
Risk Management Plans (RMPs)
Develop and maintain comprehensive RMPs that meet Health Canada and international pharmacovigilance requirements. TIVMEK designs proactive strategies to identify, assess, and mitigate potential safety risks throughout the product lifecycle. Our team supports the preparation of initial RMP submissions, periodic updates, and alignment with evolving regulatory expectations to ensure ongoing product safety and compliance.
Health Canada Interactions
Coordinate and facilitate all communications with Health Canada to ensure efficient and productive regulatory engagement. TIVMEK supports clients in planning and conducting pre-submission and clarification meetings, preparing briefing packages, and managing information requests during review. Our team helps anticipate agency questions, craft clear and evidence-based responses, and maintain strong regulatory relationships to streamline the approval process and reduce review delays.
Master Files and Amendments
Prepare, submit, and maintain Master Files (MFs) and product amendments in compliance with Health Canada’s regulatory framework. TIVMEK ensures that all technical, manufacturing, and quality information is accurately documented and securely referenced to support partner submissions. Our team manages updates, cross-references, and confidential data exchanges efficiently—facilitating seamless collaboration between sponsors, manufacturers, and Health Canada throughout the product lifecycle.
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Montreal, QC
Canada