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Validation

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Our philosophy on validation combines practicality and compliance. We design, develop and execute programs that help you qualify YOUR equipment and validate YOUR processes and not those of another company. Our unique bottom-up approach to validation consists in learning and understanding your operational needs in order to validate only those activities that are relevant to you, so that your equipment gets qualified for its intended use and your processes get validated to meet regulatory requirements. We intervene at various levels of your projects and offer validation activities that include

  • Documentation Preparation (VMP, CVMP, CSVMP)
  • IOQ/PQ design, execution and reporting
    Cleaning Validation
  • Periodic qualification, ongoing validation and re-certification

QUESTIONS ABOUT A PHARMACEUTICAL ISSUE? ASK OUR EXPERTS.

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WHAT WE DO

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We are consultants to the regulated life science industries. We help clients achieve and maintain full compliance with Health Canada, FDA, EMEA and WHO regulatory requirements. Our consultants facilitate commercialization of your new products and help you interface with various agencies to address regulatory concerns.

In addition to providing strategic and management consulting services, we bring technical expertise in quality assurance, project management & facilities commissioning, productivity & efficiency improvement, outsourcing & supply chain management, validation, and regulatory compliance.

WHERE WE WORK

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From our offices in Canada and the United States, our consultants provide services to firms across the Americas, Europe, Asia and the Middle East. Our multicultural and multilingual professionals are uniquely positioned to optimize collaborations with your teams, no matter where you are located.

Lesirg Consultants enjoy strategic collaborations with quality auditors, consultants, and professionals in key regions of the world allowing seamless project transition, and team integration.

Ask One of Our Experts!

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We’re here to help answer your questions. Pharmaceutical matters can be complicated, our experts are on hand to help inform you of every aspect regarding your topic.

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