Custom Services to Meet Your Requirements

In today's global marketplace, the development and marketing of medical products is highly regulated with strict governmental requirements both domestically and internationally. Since 2001, Lincé Consulting has provided regulatory, clinical, and quality assurance consulting services to help medical product manufacturers meet those requirements. Our team has extensive FDA, industry, and healthcare experience and a thorough understanding of product development and testing, governmental approval processes, and compliance and quality assurance systems.

Hiring an expert by the project, hour or day optimizes your efficiency because you can focus on what you do best and leave the rest to us. Our experienced professionals can quickly answer your regulatory, quality and clinical questions. Any size organization or project can benefit from our expertise to help them navigate through the myriad of US and international regulatory mazes. Lincé Consulting has successfully provided Regulatory, Quality and Clinical services to a broad range of clients. We can help you get your product successfully into the marketplace in the shortest possible time and maintain compliance.

Overview of Services:

  • Vast knowledge and utilization of IDE, 510K, PMA, IND, NDA, cGMP/QSR, ISO, GLP, GCP, MDD and various international regulations and requirements.
  • Extensive experience in working with FDA and international regulatory agencies to obtain marketing clearances/approvals.
  • Due diligence for potential investment opportunities.
  • Creative strategy development skills to get your product to market in the shortest possible time.
  • Clinical trials design and management in both the US and international markets.
  • Extensive experience in working with domestic and international regulatory agencies to obtain and maintain compliance.
  • Proven development and implementation skills.
  • Trained Quality Systems Auditors for cGMP, QSR and ISO compliance.
  • Regulatory, Clinical and Quality experience in:
    • General Surgery/ Laparoscopy
    • Gynecology / Infertility
    • Cardiac Surgery
    • Cardiology
    • Peripheral Vascular Disease
    • Orthopedics  
    • Women's Health
    • ENT
    • Trans-dermal Drug Applications
    • Combination Products


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