At the product planning stage Anson can help clients develop effective clinical testing and market approval strategies and anticipate and plan for pre and post-market compliance issues. We assess the impact of FDA policies and requirements at the product planning stage and develop effective strategies and plans for implementing and documenting compliance throughout the development cycle.

Anson supports:

• Communication and continuing liaison with FDA and EU regulators
• Assessment of regulatory classification and associated compliance, clinical, and marketing approval issues.
• Assessment of clinical and marketing approval issues
• Development of strategies and plans for clinical testing, market approval submissions, and compliance
• Support of the development design control and documentation process

Anson provides support for all aspects of the design, execution, and documentation of preclinical and clinical testing to ensure data integrity and clarity, and regulatory compliance.  When clinical research is required to support R & D efforts, regulatory approval, reimbursement decisions, or marketing strategies, Anson helps Clients develop the clinical strategies and protocols that will result in efficient and effective data gathering and analysis. As with all Anson services, we take a holistic, integrated approach to building a clinical trial strategy that will not only ensure ethical compliance, but will also avoid devastating delays in the start-up, data gathering, and data analysis portions of the clinical trial process. For medical device trials that involve relatively few patients and sites, Anson can design and manage the entire clinical trial process.  For larger trials, we can provide project management and specific clinical trial resources in partnership with qualified Contract Research Organizations (CROs) who specialize in device trials.

Anson supports:

• Pre-Clinical services
  • Biocompatibility and toxicology planning
  • Clinical Services
    • Medical/Technical consulting for protocol design and development
    • Biostatistics and data management planning
    • IDE preparation, submission and related FDA communications
    • Consent form development
    • Study Initiation Activities
      • Investigator selection and qualification
      • Investigator meeting planning/implementation
      • Assistance with IRB submissions
      • Pre-study site monitoring/qualification
      • Patient recruiting strategies
      • Overall Study Management
        • Project Management
        • Study site monitoring
        • Adverse event management
        • Management of study supplies
        • Oversight for data management, analysis, and final report writing for FDA submissions (PMA ,(510(k), and NDA) and for CE Marking
        • Auditing
          • GLP
          • GCP (sites, sponsors)
          • IRB

     

Anson works with Clients to develop submission strategies optimized to support marketing objectives, to assemble appropriate submissions, and to provide supportive liaison throughout the regulatory review process.

Anson begins each medical device regulatory approval project by considering market claims the Client wishes to support, as well as planned future upgrades and successor products. Through communications with the agency and extensive experience with a wide variety of devices, Anson can identify the regulatory pathway that best fits the client’s market objectives and resources and develop an effective product approval strategy.

FDA Liaison – Anson consultants interact daily with the FDA Center for Device and Radiologic Health (CDRH) in providing liaison and establishing positive relationships on behalf of Clients. They are experienced and adept at using planned and orchestrated pre-submission meetings with FDA to establish clear criteria for approval, and assembling submissions that clearly demonstrate success in meeting them. These planning and preparation steps help our clients to avoid delays and respond effectively to any FDA questions that do arise.

Anson supports:

• Premarket Notifications [510(k)]
  • Predicate device research
  • Assist with writing/assembling the 510(k)
    • Indications for Use
    • Device descriptions
    • Summary and conclusions of pre-clinical and clinical studies
    • Proposed labeling
    • Other required sections (user manuals, etc.)
• Assembly/filing/tracking of 510(k) through clearance
• Premarket Approval (PMA)
  • Organize project team
  • Investigational Device Exemption (IDE) application/tracking
  • Assist with writing/assembly of the PMA
    • Indications for use
    • Device description
    • Alternative practices & procedures
    • Marketing history
    • Summary and conclusions of pre-clinical and clinical studies
    • Proposed labeling
    • Other required sections
• Filing/tracking of application
• Humanitarian Device Exemptions (HDE)
  • Assist with writing/assembly of the HDE application
  • European CE Mark
    • Technical dossier preparation
    • Selection of notified bodies
    • Understanding of labeling requirements
    • Post-market surveillance compliance
    • Canadian Product & Establishment Licenses

Anson provides comprehensive quality system and compliance services for device, drug, biologics and combination product manufacturers.  We support all aspects of quality system design and maintenance, risk assessment and management, regulatory reporting, and enforcement action responses in a manner that enhances effective management control and resource allocation.  Our services focus on establishment, enhancement, and maintenance of cost-effective systems to meet our Clients’ quality goals as well as regulatory requirements. We provide auditing, validation, corrective action, and training support for established companies and quality systems design implementation, and interim management support for early stage companies.

At a corporate level, Anson provides services to assist senior management in assessing and managing risk and effectively allocating resources.  When remediation is required, we can assemble and lead project teams with the required depth, experience, and credentials to identify and recommend timely solutions for major compliance problems.  Our experience in effective communication with regulators allows us to focus corrective actions and responses on the right issues and avoid unnecessary delays.

Anson supports:

• Quality Systems Services:
  • Quality System design and implementation
  • Quality System audits and assessments
  • Corrective Action Plans
  • Computer systems validation
  • Mandatory Responses to FDA
  • Corporate Compliance Services:
    • Corporate compliance assessment and benchmarking
    • Responses to FDA Observations (483′s) and Warning Letters
    • Compliance remediation plans
    • Management Review support
    • On-site employee training seminars
    • Due Diligence audits and assessments