An Efficient and Effective Pathway
To Market Approval

We factor in global issues and regulatory requirements upfront.

Proper strategy, planning and execution are the keys to success

Global Regulatory Approval

Lincé Consulting provides a full range of US and international regulatory services to help take your medical product from concept to approval in the most efficient time possible. Achieving a balance that ensures products are safe and effective while maintaining efficiency in a regulated and ever-changing environment is crucial. The ability to adeptly navigate these dynamics is paramount for success.

Delivering on a Global Scale
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
  • Translating regulatory submissions
  • The time consuming, confusing and resource intensive nature of global approvals

However, all can be achieved with the proper strategy, planning and execution. Lincé Consulting factors in the global issues up front to ensure an efficient and cost effective process.

Global Regulatory Submissions

Quicker Approvals and Fewer Demands on Your Team
Regulatory submissions are critical to moving the product quickly to market. Every regulatory 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.

Clean and Concise Regulatory Submissions
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.

Longstanding Relationships with FDA and International Regulators
We excel in communicating effectively with global regulatory authorities. Our team brings vast experience in negotiating and engaging with the FDA and international regulatory bodies, fostering strong relationships and deepening our expertise to guide you through intricate regulatory environments successfully. Our proven track record is grounded in enduring partnerships with regulatory officials.

Meeting Preparation
We can help your company prepare for regulatory agency meetings through practice question and answer sessions and other techniques.

Global Regulatory Services

  • Product Classification Strategies and Planning
  • Strategic Planning from Concept to Post-Market
  • Premarket Notification 510(k) Submissions
    • New products
    • Product changes
    • New intended use
  • De Novo Applications
  • Premarket Approval Applications
    • New applications
    • Supplemental applications
  • Investigational Device/Drug Exemptions
    • FDA applications
    • "Abbreviated" requirements
    • Protocol development
  • Mandatory Medical Device Reporting
  • Labeling and Advertising Review
  • Import/Export Approvals
  • Participate as Regulatory Representative on Project Teams
    • Support continued design and development activities including review of design and development documentation related to the regulatory filing preparations (product specifications, risk management, design and development plans, labelling and more)
    • Performance testing protocol and report reviews
    • Resolution management of identified deficiencies resulting from the documentation provided by company and/or contract manufacturer/s
  • Provide Guidance to Project Teams on Regulatory Compliance and Submission Strategies and Requirements
  • Provide Project Team Support
  • FDA Representation/Official Correspondent/US Agent
  • Compliance Crisis Management
    • FDA warning letters
    • Consent decree representation
    • Recall strategies and management
  • EU MDD/MDR/IVDD/IVDR Compliance
    • CE mark
    • Technical files/design dossiers
    • Notified body, authorized representative and competent authority liaison
  • Other Global Regulatory Submissions and Compliance
  • Determine Reporting Requirements and Composing and Submitting Required Reports to Regulatory Authorities
  • Regulatory Review of NCR’s/Deviations and Rework Orders
  • Regulatory Review of Complaints
  • Support in Preparing for Successful Regulatory Meetings Including:
    • Presentation development
    • Practice Q&A sessions
    • Additional tailored techniques honed over the years
  • Due Diligence for Potential Investment Opportunities/Strategic Partners
Our Services
  • Regulatory
  • Clinical
  • Quality
  • Project Engineering

Ready to Get Started?