Innovation of medical products requires a planned, staged approach from concept to commercialization. You want your new investigational device to become the standard of care and enhance patients’ lives. Consult with Avania for a strategic, coordinated approach to ensure your clinical development process and market introduction go smoothly.
Strategic Preclinical Consulting
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.
Preclinical test planning
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.
Strategic Clinical Program Consulting
In tandem with preclinical strategy development, partner with us for a clinical program strategy that will move your product forward.
Our specialists, who are intimately familiar with the challenges in a wide range of therapeutic indications, have a clear understanding of the marketplace. With this in mind, we will assess your needs carefully and design a program to meet your goals.
Protocol development and feasibility
Our team will help you development an effective clinical protocol, emphasizing appropriate endpoint selection, eligibility criteria, and data collection guidelines. We also conduct comprehensive country and protocol feasibility assessments to ensure efficient use of your time and resources. For more, see our Clinical Trials page.
Strategic regulatory planning
Let our team make sure you are prepared and help smooth your interactions with regulatory bodies. For more, see our Regulatory page.