Being able to understand and interpret the current life sciences regulations requires an in-depth awareness of how to apply the standards to enterprise facilities and operations. Maetrics consulting services not only deliver an effective strategy for handling compliance issues, but our team has the skill to go beyond analytical assessments and collaborate with clients to implement the needed solutions.

This hands-on approach is based on decades of experience with global regulated body requirements and our involvement with regulatory committees since our founding in the mid-1980s. Since our focus is exclusively on the life sciences industry, we provide comprehensive compliance solutions that are customized to a client’s operations and business objectives.

Building, Executing, & Leading Compliance Solutions

As life sciences companies face ongoing compliance challenges, increasing market demands and the drive to reduce costs, Maetrics occupies a place of leadership in the consulting field. Based on our knowledge and resourcefulness, we can implement full-service solutions that ensure compliance is attained and a path to business growth is in place. With experience across the industry, our consultants deliver strategies in a broad spectrum of areas that include but are not limited to the following services:

  • Comprehensive remediation strategies
  • FDA mock inspections for GMP, GLP and GCP environments
  • CAPA handling and closure
  • Preparation of responses to FDA 483, citations, and warning letters
  • Compliance audits, assessments, and gap analyses
  • Validation audits
  • Regulatory strategy development
  • Complaint handling and recalls
  • Supply-chain audits
  • Medical device audits for 21 CFR Parts 820 (QSR and QSIT audits)
  • Pharmaceutical audits for 21 CFR Parts 210/211, 110, and 107/108
  • ISO 9001/14001
  • Computer systems audits and Part 11 assessments and remediation

Maetrics’ ability to assess where compliance improvements are needed, utilize best practices for resolving them and remaining flexible and agile during the execution of the plan of action is what distinguishes our organization from other consulting firms. We’ll ensure quality and safety standards are met while helping drive business goals.