Consultancy, Regulatory Compliance and Auditing

Where our expertise can make a difference

Consultancy

Special Knowledge, Expert Advice

NSF stays at the leading edge of pharmaceutical consulting and keeps abreast of every major industry issue. Our pharmaceutical consultants can advise you on a broad range of regulatory and technical matters, including:

  • Implementation of cost-effective, compliant quality management systems
  • Reduction in deviations and implementation of effective CAPAs
  • Assistance with responses to regulatory inspection reports, warning letters, etc
  • Troubleshooting on a wide range of technical problems
  • Advice on clinical study design and evaluation: patient population identification, study site evaluation, endpoint selection, statistical analysis plans, study reports and manuscripts, and publication development
  • Review of validation plans and completed studies
  • Regulatory compliance for computers and automated control systems
  • Regulatory submissions: fast-track designation, IND, ANDA, NDA, and BLA filings as well as post-marketing submission support (PAS, CBE-30 and REMS reports)
  • Meeting preparation: pre-IND, end-of-phase-2 (EOP2), and advisory committee
  • Specialist microbiological advice
  • Specialist advice on water systems and autoclaving
  • Global regulatory filings
  • Help with understanding the root cause of deviations and what leads to human error
  • Reviewing practices to lead to human error prevention

  • GMP Compliance

    We can perform an in-depth audit of your operations, or those of a third party, to assess current levels of compliance with international GxP regulations and expectations.

    We don’t just tell you where you fail to comply, we provide essential, pragmatic advice on how to achieve regulatory compliance in a a cost-effective way. Additionally, we will work with you to ensure that remedial action plans are comprehensive, are effectively implemented and where appropriate, fully documented.

    We partner with you to add value to your business!

  • EU and FDA Inspection Readiness

    We have extensive experience of preparing companies throughout the world for MHRA or other EU regulatory inspections and our success rate is enviable.

    Perhaps more surprising is our excellent record of preparing European clients for FDA inspections. We offer many advantages over US-based consultancies in this respect:

    • We are totally familiar with FDA regulations and expectations during inspections because of our extensive work with US-based clients
    • We have practical experience of how the FDA carries out overseas inspections, whereas many US consultancies have experience only of domestic investigations, which are very different both in duration and focus
    • We have strong cultural links to Europe, but we also share a common language with the USA and we understand the US mentality which allows us to bridge the gap between European and US philosophies
    • We are based in Europe, so the cost of using our services is lower than using US-based consultancies, and we are more accessible for support in the final preparation phases
  • Mock Regulatory Inspections

    We regularly assist clients to prepare for an imminent regulatory inspection by carrying out one or more mock regulatory audits in advance of the real thing.

    Our pharmaceutical consultants will visit your facility and carry out an inspection in the style of the relevant regulatory body (FDA, MHRA, EMEA etc.) after which we provide:

    • An in-depth, impartial and professional assessment of their current state of compliance
    • A detailed, prioritised action plan for the rectification of areas of noncompliance and vulnerability
    • Staff coaching in the sorts of questions which are likely to be asked during the inspection and how best to answer them
    • Sound, practical support and advice in the run-up to the real inspection
  • Troubleshooting and Problem Solving

    When you are very close to a problem it can become difficult to solve. Our team has considerable expertise with helping companies to systematically resolve problems associated with their products, processes, equipment and systems.

    Understanding the root cause and reducing Human Error is essential to deviation reduction and the elimination of repeat deviations. Our team has supported numerous projects helping our customers to achieve this.

Quick links

NSF Health Sciences have offices in Kirkbymoorside and Sheffield, UK and Boston and Ann Arbor, USA

A word from NSF Health Sciences

At NSF Health Sciences we are committed to improving the competitive edge of your business by improving your regulatory compliance, streamlining your Quality Systems and maximising the contribution of your people through class-leading training.

Bob Pietrowski

© NSF Health Sciences 2014

Registered Office: NSF Health Sciences, The Georgian House, 22/24 West End, Kirkbymoorside, York, UK, YO62 6AF
Registered in England and Wales No: 3432550 | Tel: +44(0)1751 432999 | Fax: +44(0)1751 432450 | Email: pharmamail@nsf.org
US Office: NSF Health Sciences, 6th floor, 129 South St, Boston, MA 02111 | Tel: 1-857-277-0060 | Fax: 1-857-284-7207 | Email: USpharma@nsf.org