Pharmaceuticals

Quality, safety, and risk management are crucial concerns within the pharmaceutical industry. Maetrics’ consulting leadership provides regulatory, compliance, and quality solutions that guide projects from the design stage to full implementation and on-going support.

Throughout our years as a leading life sciences consultancy, Maetrics has remained in step with these compliance and business challenges. In addition to our knowledge and experience, our team of industry leaders have the ability to analyze a pharma company’s operations, devise a customized strategy, and then act in collaboration with the client to develop a self-sustaining platform.

Pharma Compliance Tactics That Sustain Quality & Business Growth

Our understanding of pharmaceutical regulations has been built from years of experience with FDA and other global regulatory authorities, and knowledge of what regulators expect from pharma companies. In order to ensure quality and safety are maintained, Maetrics develops strategies that pinpoint where compliance improvements are needed and how to best take action. Rather than focusing on individual symptoms, we take a broader approach to locating and remediating systemic quality, regulatory, and compliance issues.

We can guide efforts in handling Form 483s, warning letters, consent decrees, risk management, and proactive quality strategies. We also provide quality, regulatory, and compliance guidance within the following key areas:

  • Active Pharmaceutical Ingredients (APIs)
  • Validation
  • Quality By Design (QBD)
  • Serialization/Unique Device Identification (UDI)
  • Cleanliness standards
  • Labeling of ingredients to ensure consistency
  • Lab compliance services
  • Compliance with foreign markets

As the pharmaceutical industry continues to innovate, Maetrics provides innovative approaches to industry compliance by delivering customized strategies that ensure standards are met while enabling business growth.

Have a question? Contact us today for more information on our life sciences compliance strategies.

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Connect with us

For questions regarding Maetrics services, please email information@maetrics.com.