Audit-ready. Expert-led. Built for Canadian & US compliance.
Every therapy begins with hope. But delivering on that hope demands trusted safety data and unwavering regulatory compliance.
Our experts help you navigate Canada & the US’s complex regulatory requirements. Backed by a team of 100+ specialists, we process over 300,000 adverse event reports each year — keeping your therapies compliant, audit-ready, and aligned with Health Canada & the FDA’s evolving standards.
Global compliance made simple
Navigating the complexities of global regulations doesn’t have to be overwhelming. Our integrated pharmacovigilance and medical information services are designed to streamline compliance across markets, helping to ensure you meet the rigorous standards of Health Canada, the FDA, and the EU with ease.
Backed by deep expertise and unwavering precision, our team delivers high-quality safety data collection and seamless alignment with health authorities. We empower you to confidently expand your reach, maintain compliance, and achieve success in every market you serve.
How we help
Customized reporting of safety information
Tailor solutions to meet your drug safety needs with support from our multi-disciplinary team of pharmacovigilance specialists.
Our services include:
- Standardized compliance monitoring process
- Validated databases with E2B connectivity and gateway submissions
- Reporting of Individual Case Safety Reports (ICSRs) related to adverse events (AEs) and safety information
- Product Quality Complaint (PQCs) reporting
- MedDRA coding
- Foreign risk notifications
- Literature searches
- Annual Summary Report preparation
- Reconciliation and KPI monitoring
Built for inspection readiness
Ensure your business stays ahead of health authority expectations, from intake to inspection readiness.
Keep your business ahead of health authority expectations with end-to-end support—from intake to inspection readiness. We help you navigate every step with confidence, helping to ensure compliance and peace of mind.
We provide:
- Health Canada database reconciliation and monitoring
- Risk Management Plans (RMPs)
- Risk Evaluation and Mitigation Strategies (REMS)
- Pharmacovigilance Systems Master File (PSMF) repository
- Audit and inspection support
- Procedure and documentation development
- Centralized, bilingual call centre
- Adverse events line-listing
- Solicited follow-up requests
- Aggregate/periodic safety reports (PSURs/PBRERs) Global and local literature searches and reviews
Medical information support
As the primary point of contact with the public, we recognize that medical information is the public representation of our clients. That’s why our medical information agents prioritize exceptional customer service, striving to ensure that every interaction upholds your brand’s reputation and standards.
Our Canadian-based specialists handle over 12,000 medical information inquiries annually, with a wait time of less than 30 seconds.
Offering bilingual services in English and French, plus translation capabilities in over 180 languages, we support the full lifecycle of medical information handling, from intake to submission. Our services include:
- Intake and triage for medical and product-related inquiries
- Categorization & Documentation into Adverse Events, Product Complaints and Medical Inquiries with precision and compliance
- Generation of standardized responses to ensure consistency and efficiency
- Development of letters and FAQ sheets for streamlined communication
- Support for adverse event (AE) intake through integrated workflows aligned with regulatory standards
- Product Quality Complaint (PQC) intake including facilitating return of defective product to the Quality Assurance (QA) team for an investigation
- Follow-ups for adverse events to ensure all information is received for accurate processing of the case
- Patient registries to support long-term data collection and insights
With our expertise and commitment to excellence, we deliver seamless medical information handling that helps to ensure compliance, enhances efficiency, and strengthens your connection with the public.
We handle over 12,000 medical information inquiries annually — with a wait time of less than 30 seconds.
What sets us apart
North American pharmacovigilance expertise
Experience that delivers
Lean on a proven compliance track record, built over years of supporting diverse products and therapeutic areas.
- 60+ clients and 400+ products supported across pharmaceuticals, medical devices, and natural health products
- 12,000+ medical information inquiries handled annually
- >99% compliance rate maintained year over year
From early development through post-market support, we deliver the quality, consistency, and regulatory alignment your product needs at every stage of its lifecycle. Let our experience drive your success.
Audit-ready from day one
One system. Full visibility.
Streamline your processes with a single, unified system. Our proprietary database integrates medical information and adverse event reporting into one platform. Unlike competitive offerings, this streamlined approach lets you:
- Eliminate manual data transfers between systems
- Reduce errors and accelerate case processing
- Log AEs in real time from medical information interactions
Scalable solutions
Tailor services to meet your needs, whether you're a small biotech or a global pharmaceutical company:
- Full-service pharmacovigilance for smaller organizations
- Modular support for organizations with existing systems and specific needs
Integrated with your risk management plan (RMP) and beyond
Capture adverse events directly from patient interactions within your program while facilitating seamless data flow between pharmacovigilance and medical information teams. This integration lets you:
- Link AE data with product-specific medical information
- Scale operations with automated workflows
- Improve data integrity and response times
- Enable faster responses and stronger compliance
Flexible models. Tailored support.
Choose the model that fits your needs. And scale confidently as your product evolves.
- Full-service pharmacovigilance: Ideal for small- to mid-sized companies. Includes our proprietary database and fully integrated medical information workflows.
- Focused offerings: For organizations with existing systems. We provide modular support for Health Canada requirements such as foreign risk notification, Health Canada database reconciliation, or literature searches.
Whether it’s standalone pharmacovigilance services or bespoke programs, we’ll tailor a model that fits your product, market, and goals.
