Auditors for FDA-regulated businesses

Do you need to uncover and correct issues before regulators or certifying bodies do their external audits?

We have a range of auditors available to help pharmaceutical, biotech, medical device and food companies to comply with best practices and uncover problem areas.

Value of Auditing:

  • avert recalls or reduce scope of recalls
  • reduce/eliminate errors and omissions
  • ensure supplier quality
  • ensure patient safety
  • protect your brand’s equity

Types of Auditors

MDSAP Auditors ensure you are using a comprehensive approach to quality systems. MDSAP is being instituted by an international coalition of countries including the United States, Canada, Brazil, Japan and Australia. The coalition is devoted to pooling resources, technology, and services to enhance the safety and oversight of medical devices worldwide. Therefore, the MDSAP program will be beneficial to manufacturers of medical devices who are interested in marketing and selling devices in nearly all markets.

GCP Auditors provide third-party verification that good clinical practices (GCP) are followed. GCP is an international quality standard that is provided by International Conference on Harmonisation (ICH). It ensures that safe, effective, and high-quality medicines are developed and registered in the most resource-efficient manner. GCP guidelines include protection of human rights in order to protect subjects and volunteers in a clinical trial.

GMP Auditors provide third-party verification that good manufacturing practices (GMP) are followed. These practices ensure that products are manufactured consistently to an expected level of quality.  They are also required in order to conform to regulatory agency recommended guidelines. Agencies such as FDA control authorization and licensing for manufacture and sale of food, pharmaceutical, nutraceutical, cosmeceutical and medical devices. GMP guidelines provide minimum requirements that a manufacturer must meet to assure that the products are of high quality and do not pose any risk to the consumer or public.

GLP Auditors provide third-party verification that good laboratory practices (GLP) are followed. GLP applies to non-clinical studies conducted for the assessment of the safety or efficacy of chemicals (including pharmaceuticals) to man, animals and the environment. It ensures that safe, effective, and high-quality products are developed and registered in the most resource-efficient manner.

HACCP Auditors  examine, question, evaluate and report on your safety system’s adequacy and deficiencies. The HACCP Auditor analyzes all elements of the system and reports on how well it adheres to the criteria for management and control of process safety. To do this, they know the standards and principles of auditing a HACCP-based (or process-safety) system. In addition to the CHA our HACCP auditors also hold a FSPCA PCQI Certificate.

Pharmacovigilance Auditors provide third-party verification that systems and documentation are in place and consistently followed. This ensures drug safety, protects your patients and meets regulatory requirements. Third- party audits also provide an opportunity to uncover issues in advance of formal regulatory inspections, which can lead to warning letters.

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