Primary service
Business Development & Sourcing
We source medical devices and drug products, qualify suppliers and distributors, and help both sides agree on terms.
Our capabilities
Commercial connection.
Regulatory depth.
Sourcing and business development first, with focused regulatory affairs consulting available on a limited basis.
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Focused advisory support
Regulatory Affairs Consulting
Regulatory affairs consulting is offered on a limited basis. Contact us to discuss availability.
Regulatory Strategy Development
Developing comprehensive regulatory strategies tailored to the specific needs and goals of pharmaceutical and medical device companies.
Global Regulatory Submissions
Preparation and submission of regulatory documents for product approvals and registrations in various regions, including the FDA, EMA, TGA, and other regulatory bodies.
Quality Management Systems
Establishment and maintenance of robust quality management systems (QMS) to ensure compliance with Good Manufacturing Practices (GMP), Good Clinical Practices (GCP), and ISO standards.
Clinical Trial Support
Assistance in designing and conducting clinical trials, including protocol development, site selection, monitoring, and regulatory reporting.
Regulatory Intelligence
Continuous monitoring of global regulatory changes and providing updates to keep clients informed about evolving requirements.
Product Classification and Categorization
Expert guidance on the classification of medical devices and drugs in compliance with regional and international regulations.
Discuss availability