Healthcare

PRODUCTS

  • Compliance solutions for product development agility and audit readiness.

  • Our experienced subject matter experts validate and maintain your business and mission critical information systems, including Quality Management Systems, Enterprise Resource Planning, Customer Relationship Management Systems, Learning Management Systems, Document Management, and much more.

  • There are clearly defined pathways for drug approval, and choosing the right regulatory pathway for your drug development program requires a thorough understanding of sections 505(b)(1) and 505(b)(2) of the Federal Food, Drug, and Cosmetics (FD&C) Act.

  • Advancing biologics from start to finish is highly complex and full of challenges, requiring scientific strategies and implementation.

  • Although each micro-manufacturing cell is considered autonomous, MTD must also depend on proper quality assurance techniques, which come in the form of micro metrology and testing.

WHITE PAPERS AND CASE STUDIES

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