Meeting Your Specific Quality And Compliance 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 in product design, preclinical/clinical testing, manufacturing, and marketing are aligned and meet established global standards while remaining flexible to meet your specific needs.
We understand global requirements and we strive to develop quality systems that meet or exceed global regulatory requirements that will work well as you add markets and products to your portfolio. Our team can ensure your product is designed to comply with applicable product safety standards. We can help you establish the quality systems and quality products you need to prevent deficiencies typically identified during quality audits or the problems that result in a product recall.
Global Quality Services:
- Quality System Development and Implementation including product development, design control, management responsibilities, corrective and preventive actions, complaint handling process, post marketing survellance.
- Standard Operating Procedure 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 and employee cGMP/QSR/ISO training.
- Implementation of corrective and preventive actionsto ensure compliance with internal and government requirements.
- Development of training programs and procedures to improve company and department productivity and efficiency.