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Manufacturing & Quality

Mentara assists companies by integrating quality assurance and regulatory compliance with business operations for drugs, biologics, and devices. Our teams utilize a business approach to domestic and international regulatory and quality compliance issues that includes:

  • Establishing manufacturing operations from design through commissioning
  • Assisting in full compliance with all regulatory requirements for pharmaceutical, medical device, and biologic products and substances
  • Creating manageable documentation systems appropriate to the company’s research/operational environment
  • Conducting compliance audits, gap analysis, vendor assessments, due diligence, pre-market approval inspections
  • Establishing and implementing customized Quality Systems
  • Providing all types of GXP audits with recommended actions
  • Assisting in responses to regulatory inspections, warning letters, import detentions, etc.
  • Providing training seminars inGXP implementation

Understanding that well documented quality management is needed throughout the development process, Mentara provides guidance to navigate increasingly rigorous application of regulatory requirements. With extensive experience in implementing quality management systems, Mentara works with your company to create the easiest working environment to become and remain compliant with any regulatory body.

We provide the required expertise, insight, and hands-on experience to create an infrastructure to carry the company from development through clinical trials to full commercialization.