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NSF International

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NSF International

Regulatory and Compliance Consulting, Auditing and Pharmaceutical Training

Science

NSF International’s pharmaceutical services include world-class regulatory and compliance consulting, auditing, residential, on-site and online pharmaceutical training.

Recent public health concerns and challenges have underscored regulators’ proactive pursuit of compliance in the pharmaceutical industry. The market’s need for outsourced, independent, third-party pharmaceutical and biotech support services has been recognised by industry experts.

Regulatory and compliance support, auditing and training services

NSF offers regulatory, compliance, auditing and training solutions that are tailored to your industry requirements and company-specific objectives.

Made from former EU and US Food and Drug Administration (FDA) officials, as well as industry experts, the company’s staff enable it to combine global regulatory knowledge with industry best practices to help its clients achieve what they need to, all while remaining updated during an increasingly turbulent time of change.

NSF cares about its clients, which is why more than 87% come back for more.

Pharmaceutical and biotech support services

NSF’s provides you with solutions across the product lifecycle, including:

•   Customised education programmes that will change behaviours, improve performance and future-proof your organisation. You are only as good as your people.

•   Qualified person education – More people have become qualified persons (QP) in Europe through NSF’s QP training programme than any other training provider

•   Remediation consultancy – Helping you successfully manage warning letters, consent decrees, import alert notifications, World Health Organisation (WHO) delisting and removal of manufacturing and marketing licenses in the EU. With NSF, you will become better prepared and emerge as a stronger company

•   Quality system simplification, implementation, compliance assessment and benchmarking against best industry practice – NSF wants you to have a quality system that will provide you with commercial advantage. One that is simple and effective

•   Regulatory inspection readiness and mock inspections – NSF will help you to succeed in your next FDA, EU or WHO inspection

•   Data integrity assessments – Let NSF help you find and close the gap before it’s too late

•   Helping you to error-proof your processes and systems and drive continuous improvement

•   Leadership development and coaching

•   Auditing of third parties and suppliers – Let NSF help you to sleep easy at night

•   Due diligence audits – NSF will help you spend your money wisely

•   Auditor certification – NSF will independently certify your good manufacturing practice (GMP) auditors so you can be confident with their findings

•   GMP remediation – Programmes that provide a sustainable, proportionate and comprehensive roadmap to survive and then thrive in the field of bio and biosimilar manufacturing

•   Corporate due diligence, risk assessment and specialist consultancy when acquiring or merging with bio-production facilities outside your organisation

Medical device consulting, training and auditing solutions

NSF offers comprehensive medical device consulting, training and auditing.

The company helps clients navigate international regulatory hurdles throughout the product lifestyle. It has combined regulatory and industry expertise across all therapeutic areas and provides customised consulting services in a number of areas.

NSF will help you enhance and embed the right culture throughout your organisation.

Contact

Europe Office:

The Georgian House
22/24 West End
Kirkbymoorside
York, YO62 6AF, UK
Phone: +44 (0) 1751 432 999
Email: pharmamail@nsf.org
Web: www.nsfpharma.org

US Office:

2001 Pennsylvania Avenue NW
Suite 950
Washington, DC 20006 USA
Phone: 202 822 1850
Email: uspharma@nsf.org
Web: www.nsfpharma.org

Consulting, Auditing and Assessment

NSF International’s unique team of ex-regulatory agency inspectors and highly experienced industry professionals provide authoritative consulting and auditing services to major pharmaceutical and biopharmaceutical companies and regulatory agencies worldwide.

NSF provides in-depth, expert assessment of technical issues and help outsource your entire supplier audit programme, as well as specialist services in areas such as cost-effective quality management; manufacturing of major dosage forms, including sterile and biotech products; pharmaceutical packaging; clinical trial manufacturing; supply and good clinical practice (GCP); and pharmacovigilance (PV); as well as…

Regulatory / Clinical Support

NSF International provides regulatory solutions and strategic input across a wide variety of therapeutic areas.

The company offers expert US Food and Drug Administration (FDA) regulatory / clinical support and consulting services to all sizes of pharmaceutical and biotech companies, investment firms and regulatory or litigation counsels needing experts to interpret or navigate the intricacies of FDA pharmaceutical and biotechnology regulations. NSF provides regulatory strategies based on your corporate objectives…

Remediation / Quality Systems Compliance

NSF International has substantial experience in creating, implementing, reviewing and remediating pharmaceutical quality systems (QS) for a variety of organisations.

Strong and robust quality systems are required for companies to consistently and reliably produce safe, high-quality products and services. Regulatory inspections from authorities may require pharmaceutical biotech companies to respond to specific enforcement actions. NSF International helps with regulatory compliance through an experienced team, which includes former US Food and Drink Administration (FDA) and UK…

Data Integrity Support

Drawing on NSF International’s years of experience both in industry and within a regulatory authority, the company provides a full range of data integrity auditing, assessment and training services from data integrity-focused audits to auditor training.

NSF’s data integrity and assessment audits help you find issues, its remediation consulting services help you fix your data integrity issues, and its training helps you prevent future data integrity issues.

Investigation and CAPA System Assessment and Training

Pharmaceutical failure investigations and corrective and preventative action (CAPA) system weaknesses are consistently among the top most frequently cited regulatory observations.

The most common regulatory concern is that investigations fail to thoroughly conduct root cause analysis (RCA) and fail to link corrective and preventative actions to the root causes identified. Often companies are cited for not considering the potential magnitude of an event or not considering other batches previously produced and possibly released into the market.…

Pharma Training and Education

NSF International is known worldwide for its high-quality pharmaceutical training and education.

The company offers comprehensive training programmes that are designed to develop the knowledge and skills needed to meet the challenges of a global and complex pharmaceutical industry. Its programmes are frequently global in scope and may be adapted to a local language and culture. NSF International finds that companies that proactively seek NSF’s educational services…
Quick Contact NSF International
Quick Contact NSF International

Join NSF’s Robyn Meurant at the BIVDA Near Patient Testing Working Party in London

Robyn Meurant will participate in the Near Patient Testing working group on November 14 in London, UK.
13th November 2019

New Data Integrity eLearning From NSF

Our NEW Data Integrity eLearning course is now live!
11th November 2019

NSF to Attend CPhI Worldwide 2019 in Frankfurt

Join NSF’s Lynne Byers, Catherine Kay, Howard Broadbridge and Martin Krainz at the CPhI Worldwide exhibition on November 5-7, 2019.
24th October 2019

NSF International Expands Health Sciences Group With Acquisition of Majority Interest in Amarex CRO

The transaction creates a single access point for medical device and pharma/biotech product developers seeking integrated, expert services throughout the...
21st October 2019

NSF to Host Webinar: The UK Qualified Person – Best Practice for Gaining Eligibility

NSF will be hosting a webinar about the best practices for gaining eligibility as a UK Qualified Person on 8...
26th September 2019

Join NSF’s Robyn Meurant and Rachel Carmichael at the MMPathIC Event, September 23, 2019

The Manchester Molecular Pathology Innovation Centre (MMPathIC), in collaboration with the Diagnostics and Technology Accelerator (DiTA) and NIHR Manchester Biomedical...
16th September 2019

NSF’s Responsible Person Course Is Now MHRA Recognized and Cogent Gold Standard Approved

We are very pleased to announce that NSF’s Responsible Person and Good Distribution Practice course now meets the Cogent Gold...
28th August 2019

NSF International’s Courses for September 2019

NSF International's September courses are filling up fast, book now to secure your place.
19th August 2019
Quick Contact NSF International


What Does Your Company QMS Look Like

A highly diversified pharmaceutical company based outside of Europe has grown by acquisition and as a consequence has developed a...
17th September 2018

Does Your Pharmaceutical Quality System Improve Your Competitive Edge

There are some companies that believe their pharmaceutical quality system (PQS) exists purely for regulatory compliance. We think this attitude...
22nd August 2018

Preparing For A Regulatory Inspection

Problem: A project had been running for ten years and had not had a regulatory inspection. There had been many...
17th August 2018

NSF details how Changing Behaviours can Reduce Risk and Cost

A client investigation identified inconsistencies in hand sanitization, failed retraining efforts and continued problems at an annual cost of over...
14th June 2017

NSF Provides Customised Education on Error Prevention and Reduction

One of NSF's clients was unhappy with their annual $1.2m error bill and unnerved by their legacy risk. Most deviations...
27th February 2017
Quick Contact NSF International
Quick Contact NSF International


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