Establishing and Maintaining Scalable Quality Management Systems

Developing quality systems appropriate for your organizational infrastructure, product risk and complexity of product and manufacturing processes.
ENABLING COMPANIES TO BRING QUALITY PRODUCTS THAT ARE SAFE AND EFFECTIVE TO GLOBAL MARKETS AS QUICKLY AS POSSIBLE

Understanding Global Requirements and Your Needs

Lincé Consulting takes the specifics of your company and product into consideration up front, so you get a compliant quality system designed for ease of use and efficiency – for your specific needs.

It is our goal to ensure that the systems and programs used from the product development through post-approval lifecycle management are aligned and meet established global standards while remaining flexible to meet your specific needs.

We have a deep understanding of global requirements and are committed to developing quality systems that not only meet but exceed global compliance standards. Our goal is to tailor these systems to align seamlessly with your organizational infrastructure and product risk profile. They are designed to evolve alongside your business as you expand into new markets and add products to your portfolio.

Prevent Deficiencies and Potential Recalls
Our team specializes in ensuring that your product is designed to comply with all pertinent product safety standards. We can help you establish robust quality systems, and develop high-quality products that anticipate and address issues commonly identified during quality audits, mitigating the risk of product recalls and audit findings.

Global Quality Services

  • Quality System Development, Implementation and Maintenance
  • Standard Operating Procedures, Forms, Work Instructions Development and Implementation
  • Preparation and Support for Your Regulatory Inspections with Trained Quality Auditors for cGMP, QSR and ISO Compliance
  • Preparation of Technical Files and Design Dossiers
  • Internal Audits & Gap Assessments
  • Employee cGMP/QSR/ISO Training
  • Implementation of Corrective and Preventive Actions to Ensure Compliance with Internal and Government Requirements
  • Development of Training Programs and Procedures to Improve Company and Department Productivity and Efficiency
  • Supplier Qualifications
  • Prepare Responses to Regulatory Agencies Findings
  • Conduct Diagnostic Audits (Pre-Assessment/Gap Analysis/Recommendations)
  • Perform Management Representative Function
  • Perform Document Control Function
Our Services
  • Regulatory
  • Clinical
  • Quality
  • Project Engineering

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