Regulatory Strategy and Planning
A clear regulatory strategy serves as the foundation of all quality development plans for a new medical product. Knowing the global regulatory requirements and applicable conformance standards for each new product is critical to sound planning and financial management.
Regulatory and Technical Due Diligence
If you are considering investment in, or merger with a medical device firm, Paladin Medical will work with your advisors to conduct due diligence audits of regulatory and technical documentation. We can help determine whether new medical device firms have sound regulatory and development plans.
For specific experience details and project profiles, please see the Paladin Medical Profiles in Success (pdf).
Paladin Medical Key Services
• Global product requirements.
• Process application for exporting to regulated nations.
• Source investigators, laboratories, and testing services with medical device experience.
• Strategies to achieve regulatory and business objectives within financial goals.
• Import requirements for most medical device markets.
• Regulatory submission services and compliance consulting.
• Serve as US Agent.
• Due diligence assessments for potential acquisitions and investments.
©2008 Paladin Medical, Inc.
Global Regulatory Strategy and Due Diligence
International Regulatory Submissions and Exports
Paladin Medical, Inc. will help you think globally. If your company intends to market internationally, you need to know how your product will be regulated in major medical device markets. Compliance with FDA export and import regulations ensures smoother international access.
Companies based outside the USA will find Paladin Medical to be a productive and helpful service provider for submissions and compliance consulting regarding FDA regulations. Our involvement facilitates efficient entry to the US markets. Paladin Medical also serves as US Agent for numerous clients.
