Strategic Preclinical Consulting Services
We will partner with you to define, develop, document, and deliver a preclinical strategy, encompassing all aspects of product validation and verification, to bring your product to market.
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Services Overview
Avania will help you implement a sensible quality system that ensures compliance with necessary regulations without burdening you with unnecessarily cumbersome systems. Our approach focuses on the phases of product development:
- Phase I – Design development
- Phase II – Design verification and validation
- Phase III – Postmarket
- Risk management
Your unique product development plan must focus on mitigating risks your product may need to navigate and it must be updated as necessary throughout development. Assisting clients in managing product risk has allowed us to develop a broad and detailed understanding of ISO standards, FDA guidance documents, and regulatory expectations for a multitude of medical products.
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