Regulatory clarity. Global market access.
Strategic regulatory and quality consulting across the globe
Navigate global regulatory pathways with confidence.
We develop clear, risk-based regulatory strategies to support efficient approvals across the globe.
Build quality systems that withstand regulatory scrutiny.
We design and implement practical QMS frameworks aligned with ISO, GMP, GDP, and market-specific requirements.
Enable market entry and sustain compliance across the lifecycle.
From initial submission to post-market obligations, we support long-term compliance and regulatory resilience.
Regulatory Frameworks & Markets Supported
Supporting regulatory and quality activities across established and emerging global markets.
Core Regulatory Markets: Canada (Health Canada) · United States (FDA) · European Union (EU MDR)
Additional Markets Supported: India · China · Japan · Singapore · ASEAN · Australia · Middle East & North Africa · South America
Support is provided through regulatory strategy, market-specific compliance pathways, and coordination with local partners, as applicable.
Your Strategic Regulatory & Quality Partner
At RegulaWise, we support medical device, pharmaceutical, biotechnology, and veterinary companies in navigating complex regulatory environments across global markets.
Global Reach
Practical Solutions
We apply pragmatic, risk-based regulatory and quality strategies designed to streamline market entry, support audits, and maintain ongoing compliance particularly for small and mid-sized manufacturers.
Our Services
Practical regulatory and quality solutions designed for global compliance.
Quality Management Systems (QMS)
Design, implementation, and maintenance of quality management systems aligned with ISO standards, GMP, GDP, and market-specific regulatory requirements. Built to withstand audits and inspections.
Post-Market & Lifecycle Compliance
Support for post-market regulatory obligations including change management, vigilance activities, audits, and ongoing compliance requirements throughout the product lifecycle.
Regulatory gap analyses, impact assessments, and strategic guidance to support informed decision-making across product development, manufacturing changes, and market expansion initiatives.
Regulatory Intelligence & Risk Assessment
Post-Market & Lifecycle Compliance
Practical support for operationalizing regulatory and quality requirements, including importer and distributor readiness, GDP compliance, and cross-border market entry execution.
Regulatory Strategy & Market Authorization
Strategic regulatory planning and execution to support product approvals, market authorizations, and lifecycle compliance across Canada, the United States, Europe, and other regulated markets.
Stay Informed
Receive curated regulatory insights and compliance updates relevant to global life sciences markets.
Contact
Reach out for tailored regulatory support.
info@regulawise.com
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