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Consulting & Auditing

Pharmaceutical RA/QA

Pharmaceutical RA/QA

With FDA warning letters and 483s at an all-time high, it is critical that you understand the most up-to-date compliance regulations and how to avoid nonconformances.

Partnering with the right firm is key – in this climate, you can’t afford any mistakes.

Consulting

Overview

Since 1977, Oriel STAT A MATRIX has been helping companies in FDA-regulated industries to achieve regulatory compliance throughout the product life cycle.

Oriel STAT A MATRIX delivers tailored and practical solutions to guide pharmaceutical companies in effectively applying and complying with the FDA cGMPs (21 CFR Parts 210, 211), Process Analytical Technologies (PAT), and the International Conference on Harmonisation (ICH) guidance documents.

Our full range of FDA pharmaceutical consulting and training services will ensure that your company’s quality system:

  • Is properly implemented.
  • Provides controls.
  • Produces consistency and quality.
  • Manages and controls risks.
  • Integrates and supports business processes and goals.

Whether the scope of your consulting needs includes implementing a compliant quality management system, or preparing an effective response to an FDA 483 or Warning Letter, Oriel STAT A MATRIX’s team of life sciences industry experts and former FDA officials will efficiently and effectively guide you through the necessary steps.

In the highly competitive and highly regulated biopharmaceutical marketplace, the need to stay competitive and avoid nonconformances and inefficiencies is greater than ever.

Let us help you establish sustainable changes that address the FDA’s concerns and enhance your overall business quality functions. Contact us for more information.

Provided below are a variety of practice related white papers, market updates and case studies.

Oriel STAT A MATRIX’s Goal

Help our life science customers meet regulatory requirements, boost efficiency, and improve patient outcomes

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