Mock Regulatory Inspections

  • Overview
  • Benefits
  • Why Work With NSF?

Get the best possible preparation for your next regulatory inspection!

Our auditor team includes former senior FDA and MHRA regulatory agency inspectors. They have a unique insight into how inspections are performed, what inspectors look for, what makes them feel comfortable and what makes them feel concerned. They can give you first-hand experience of what it is like to undergo a regulatory audit and how best to respond to inspectors’ questions and concerns. Additionally, our experienced industry professionals can advise you on how to prepare for the inspection, what documentation to have ready, how to take notes and record events, how to prepare for the next day, etc.

NSF audits not only identify areas of weakness, but also provide sound advice on how to best address any gaps.

We can prepare you for inspections by most international regulatory agencies and we specialize in:

  • FDA inspection readiness
  • FDA pre-approval inspection (PAI) readiness
  • EU/EMA inspection readiness
  • MHRA inspection readiness
  • WHO inspection readiness
  • Health Canada inspection readiness

For more information about FDA and Health Canada related services in inspection readiness, email uspharma@nsf.org or call +1 202.822.1850.

For information on services related to European and other international agencies, email pharmamail@nsf.org or call +44 1751 432 999.

Benefits

Our unique team of auditors enables us to provide auditing and consulting services that are authoritative and respected by major regulatory agencies around the globe. NSF audits not only to identify areas of weakness, but also to provide sound advice on how to best address any gaps.

Why Work With NSF?

This case study illustrates a real-world example of how working with us can help your company.

Challenge: A privately-held Swiss medical device company developing a novel dental drug therapy contacted NSF to serve as its U.S. agent. The prefilled syringe drug product was considered an NCE and had prior clinical experience in the U.S. as a pre-Investigational New Drug (pre-IND) with the same drug substance, but with other indications using other routes of administration. The company filing the IND application had limited experience in the current regulatory expectations for product manufacture and in the conduct of a Phase I clinical study. The client also needed a comprehensive understanding of product development from the IND phase to marketing application of the drug product in the U.S. (type and number of clinical trials needed, nonclinical data needed at various phase, product manufacturing and control requirements, etc.).

Solution: NSF was involved from the (pre-IND) phase through the conduct of a Phase I/II clinical study. We led the pre-IND meeting with FDA which was followed by the submission of the original IND for a Phase I/II clinical study. NSF supported the client in preparation of the pre-IND meeting package and agency question session. For the IND, NSF supported the client in the drafting of the chemistry, manufacturing and control sections as well as clinical protocol development and drafting of the nonclinical and clinical summary sections, including identification of regulatory risk. We also screened and made recommendations for a contract research organization (CRO), a bioanalytical laboratory, a safety laboratory, clinical sites, a microbiology laboratory, an ECG service company, phlebotomists and a statistician for the conduct of the Phase I/II trial. Following the successful completion of the open-label pharmacokinetic pilot phase of the Phase I/II study at a single site, we assisted in the transition of the CRO for the main blinded portion of the trial to be conducted at multiple sites.

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