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.

Regulatory Strategy

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.

  • Experienced team with broad, in-depth knowledge of FDA requirements and procedures, including 510(k) notifications
  • Well-designed regulatory strategy tailored for your product
  • In-depth knowledge to take advantage of the time and cost benefits of obtaining marketing approval in Europe first
  • Guidance in utilizing European study information to accelerate FDA submissions
  • Free consultation for your European regulatory strategy, without obligation
  • Customized strategies to obtain CE marks
    • Assistance with notified body selection and negotiations           
    • Experts to design and control CE-marking studies to meet the demands of notified bodies
  • Teams established in Europe with ISO 9001 certified standard operating procedures that comply with ISO 14155 and ISO 13485 standards

Regulatory Submissions

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.

  • Strategic planning and overall regulatory guidance
  • Interactions with reviewing divisions of the FDA and the Office of the Ombudsman
  • Interpretation of standards and guidelines
  • Development of bench testing protocols
  • Development of biocompatibility test strategies
  • Interactions with test houses
  • Validation testing guidance and interface (electrical testing, packaging, sterilization)
  • Development of animal study designs/protocols
  • Interface with GLP animal facilities
  • Proven track record of successful ethics committee (EC) and institutional review board (IRB) submissions
  • Experience conducting multicenter trials in Europe, the Americas, and Australia
  • U.S. regulatory submissions
    • Premarket notifications – 510(k)
    • Premarket approval applications – PMA
    • Advisory committee preparations
    • 513(g) Request for Designation
    • Investigational device exemptions – IDE
    • Humanitarian Device Exemptions – HUD/HDE
    • eCopy format for U.S. device applications to be filed with the FDA’s Center for Devices and Radiological Health (CDRH)
    • eCTD format for U.S. INDs to be filed with the FDA, Center for Drug Evaluation and Research (CDER), or Center for Biologics Evaluation and Research (CBER)
    • Expert guidance throughout FDA submission and approval
  • EU regulatory submissions
    • Technical file, design dossier, and CE mark documents
    • Individual EU country registrations
  • Australian submissions
    • Preparation and submission of new client ID forms to the Australian Therapeutic Goods Administration (TGA)
    • Setup of eBusiness service access for new clients
    • Lodgment of initial Manufacturer’s Evidence applications and ongoing updates
    • Searching and suggesting GMDN codes relevant to your product
    • Preparation and submission of medical device and in vitro medical device applications
    • Preparation of Level 1 and Level 2 application audit packs for the TGA
    • Preparation and submission of full conformity assessment Applications for overseas manufacturers where full conformity assessment is required
    • Assisting local Australian manufacturers with conformity assessment applications
    • Preparation of manufacturer’s declaration of conformity documents
    • Preparation and submission of annual reports for Class IIb implantable medical devices, Class III medical devices, and active implantable medical devices (AIMDs)
    • Maintaining your Australian Register of Therapeutic Goods (ARTG) entries, post-inclusion
    • Assisting with access to unapproved therapeutic goods routes including the TGA’s Special Access Scheme and Authorised Prescriber program
    • Preparation and submission of clinical trial notification forms
    • Coordinating product recalls, recalls for product correction, and overall management of communications with the TGA’s recalls division
    • Submission of incident reports and managing communications with the TGA’s Post-Market Surveillance Branch (PMSB)
  • International Design Dossiers
    • Health Canada applications
    • New Zealand applications
    • Latin America applications
    • Asia Pacific applications
    • Expertise to lead you through the national competent authority submissions
    • Local teams with in-depth knowledge of your target country’s national requirements, guidelines, and timelines
  • Recall strategies
  • Warning letter mitigation and resolution
  • Medical device reporting (U.S., EU, Canada, Australia) and complaint handling
  • Safety and post-market surveillance (PMS) reporting
  • Comprehensive, well-designed PMS studies to optimize your product’s potential
  • Expert design, conduct, analysis, and reporting for PMS studies
  • Results that strengthen your marketing and sales efforts through increased scientific credibility and product exposure
  • Guidance for entire regulatory process
  • Experience in working closely with EU notified bodies
  • Assistance with all regulatory discussions
  • Vigilance for evolving regulatory requirements by country and region
  • Tracking/trending product complaints
  • Complaint reporting to regulatory bodies (U.S., EU, Canada, and Australia)
  • Corrective and preventive actions (CAPA) initiation
  • Metrics for management reviews
  • Premarket and postmarket
  • ISO 13485 certification
  • Established procedures and experience in complaint handling
  • Partnership with your team
  • Assistance executing the prescribed field action strategy including product recall
  • Facilitation of necessary initial, follow-up, and closure reports to regulatory bodies (U.S., EU, Canada, and Australia)
  • Timely and compliant reporting
  • Assistance in developing appropriate corrective and preventive actions required by your quality system