Regulatory

An Efficient and Effective Pathway To Market Approval.

Global Regulatory Approval:
Lincé Consulting provides a full range of international regulatory services to help take your product concept all the way from design to approval in the most efficient time possible.
Manufacturing and delivering products on a global scale can present new opportunities for your business. However, the process of launching a product globally can be intimidating and can include many challenges such as running a clinical trial across multiple time zones, conducting an investigator meeting in a foreign language or translating regulatory submissions. Global approvals can be time consuming, confusing and resource intensive. However, they can be achieved with the proper strategy and planning. Lincé Consulting factors in the global issues up front.

Global Regulatory Submissions:
Regulatory submissions are critical to moving the product quickly to market. Every agency requires them and each has their own format and content requirements that need to be considered. Clean and concise submissions that are right the first time will cut down on the number and extent of deficiency requests from a regulatory agency. On-going communications with regulatory agency staff members, as well as presentations at regulatory agency meetings are key to success.
Our team is proud of their ability to create clean and concise regulatory submissions for major agencies worldwide.  This results in quicker approvals and fewer demands on your employees to locate missing information and formulate answers to questions.
Effective communication with global regulatory officials is also one of our strong points. Our track record is based on longstanding relationships with regulatory officials. Finally, we can help your company prepare for regulatory agency meetings through practice question and answer sessions and other techniques.

Global Regulatory Services:

  • Strategic Planning from Design to Market
  • Premarket Notification 510(k) Submissions
    • New Products
    • Product/Process Changes
    • New Intended Use
  • Premarket Approval Applications
    • New Applications
    • Supplemental Applications
  • Investigational Device/Drug Exemptions
    • FDA Applications
    • "Abbreviated" Requirements
    • Protocol Development
  • Mandatory Medical Device Reporting
    • Complaint System
    • Service Systems
    • Complaint Control System
  • Labeling and Advertising Review
  • Import/Export Approvals
  • FDA Representation/Official Correspondent
  • Compliance Crisis Management
    • FDA Warning Letters
    • Consent Decree Representation
    • Recall Strategies and Management
  • EU MDD Compliance
    • CE Mark
    • Technical Files/Design Dossiers
    • Notified Body, Authorized Representative and Competent Authority Liason

 

 


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