Aligning clinical strategy with desired marketing indications by using FDA input and interactions
Our team of experts are ready to assist with any of your regulatory needs, starting with FDA registration to quality consulting. Whether your company is just beginning the regulatory process for the first time or you need a partner of experts to delegate the process to, we are here to help.
Regulatory Consulting
- Regulatory Strategy Development
- Device Classification and Intended Use Development
- Development of Testing Plans
- Regulatory Submission Preparation, including:
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- 513(g)
- 510(k)
- Investigational Device Exemptions (IDEs)
- Pre-Market Applications (PMAs)
- Emergency Use Applications (EUAs)
- Post-Market Surveillance
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Quality Consulting
- FDA and International Quality System Compliance
- 21.CFR.820 Quality System Regulations
- ISO 13485 – Medical Device Quality management system requirements
- Corrective and Preventative Action (CAPA) program oversight
- Quality system management and development
- Due Diligence
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Clinical Strategy Development
- Clinical Strategy and Planning including:
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- Clinical Protocol Review
- CRO selection
- Data management development
- Development of Clinical Study Design
- Clinical Trial Safety Reporting
- Investigational Product Management for International Clients
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International Regulatory Consulting
- Health Canada
- European Union Medical Device Regulations (EU MDR)
- Pharmaceuticals and Medical Devices Agency (PMDA)- Japan
- FDA-Japan Harmonization by Doing (HBD)
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Business Development
- Personalized early marketing strategies
- Business strategy and regulatory goal alignment
- Business improvement based on quality systems
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Let’s Get Started
Contact us directly at info@addwinconsulting.com or submit the form below. Someone from Addwin will be in touch within two business days.