Strategic Preclinical Consulting Services

Our experts will guide your preclinical in vitro and in vivo testing, including writing preclinical test protocols and planning bench, animal, biocompatibility, and toxicity testing within current regulatory guidelines. We also review and write test reports for inclusion in regulatory submissions. See our Regulatory page for more.Development of quality systems

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.