In today’s ever-evolving regulatory environment, bringing a new medtech device to market is a challenge. Innovative medical products require innovative strategies to obtain regulatory clearance or approval and maintain post-approval regulatory compliance in the complex global market.
Avania’s experienced team of regional experts will partner with you to support your business objectives. Our regulatory specialists will deliver an efficient and effective regulatory strategy — and assist with submissions — enabling you to negotiate the process smoothly and efficiently.
Developing a regulatory program requires answers. Even deciding whether your new idea will be considered a drug, a biologic, a device, or a combination may be less than straightforward. You’ll need to decide:
- What is the most appropriate path to market, and do I have options?
- What is the product classification?
- How will my product be regulated?
- What are the preclinical test requirements?
- What are the quality system requirements?
- Will this product require a clinical trial?
Avania can help, with comprehensive regulatory assessments based on your technology and possible product indications. Our expertise extends across many device classifications, including those incorporating animal-derived materials. We advise clients on all aspects of regulation in the U.S., the EU, Australia, Asia Pacific, Canada, and by other local, national, and international regulatory entities.
Avania provides comprehensive submission preparation and maintenance support to clients at all stages of the medical product development process. We can develop complex regulatory strategies for you or work with your team to produce a regulatory submission that enhances your chance for product clearance with a minimum review cycle.
From pre-submission meetings through panel meetings and beyond, our team is available to assist you with basic regulatory guidance and submission support. Our expertise extends to specialized services. These may include interactions with numerous regulatory divisions such as notified bodies or FDA Office of the Ombudsman regarding scientific disputes, or the preparation of 513(g) Request for Designation documents.
Finally, our team will partner with you to ensure your post-marketing product clearance or approval is maintained throughout your product’s life cycle.