REGULATORY

Our Unique Approach


With CSSi LifeSciences It’s As Easy As One, Two, Three.

01 We help clients unlock value by engaging effectively with regulatory health authorities through regulatory plans that support your conversations and align milestones.

02 We provide a customized regulatory solution and a dedicated team throughout the life of the project based on your needs and stage of development.

03 Our staff helps you navigate the complex and evolving regulatory environment to facilitate successful and timely agency interactions.

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Regulatory Services

CSSi LifeSciences offers regulatory affairs services to help minimize product development time and accelerate product approval. Our expert team provides guidance and solutions to regulatory hurdles. We prepare numerous agency submissions each year and are experienced in handling a wide range of therapeutic areas and project types, from Class I to Class III medical devices.

Developing strategies, representing sponsors, and writing and submitting filings to regulatory authorities is our bread and butter.

We provide customized services and support the full product lifecycle for medical device products.

Regulatory Consulting and Management

  • Regulatory consulting
  • Project planning and development
  • Vendor sourcing and qualification
  • Outsourced staffing
  • Define regulatory requirements and recommendations for new products, regulatory filing strategies and post-approval changes
  • Gap assessments
  • FDA Special Designations (i.e. Breakthrough)
  • Emergency Use Authorization
  • Label development and negotiation
  • Feasibility risk assessment
  • FDA and QMS Audits
  • Advertising and promotional material review
  • Clinical Planning

Health Authority Interactions and Meetings

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In-country representation and registration
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Health authority responses to questions
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FDA Establishment Registration
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Representation with FDA and National Competent Authorities

Medical Device Submission Services

  • Medical Device 510(k) submissions - traditional and de novo
  • Premarket Approval Applications (PMAs)
  • Investigational Device Exemption Applications (IDEs)
  • 513(g) Requests for Information
  • Technical files / design dossiers for CE Mark
  • Design Master Files
  • Label and package leaflets
  • Global expansion filing support documents for ROW submissions

Medical Device Design and Developement

  • Product development and testing
  • Validation testing, methods development and oversight
  • Safety testing (3-pac)
  • Stability, ship and sterility testing oversight
  • Human factor testing
  • Device design inputs and outputs
  • Failure modes effects analysis
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