NSF International, Pharmaceutical Services

Regulatory Support, Auditing and Training Services for Drug Manufacturers

2001 Pennsylvania AVE NW Suite 950, 20006,Washington, United States of America



NSF Health Science

NSF International provides an extensive range of high-quality support services to the pharmaceutical and biotech industries.

The company’s pharmaceutical offerings include both residential and on-site training, consulting, auditing and regulatory support services, bringing high quality and safety.

Throughout 2018, NSF International:

  • Has provided services to Forbes’ 2017 top ten most reputable pharmaceutical companies and to the top 20 of Pharmaceutical Executive’s largest companies by revenue
  • Held more than 35 residential courses and workshops and over 60 global on-site training courses
  • Successfully ran more than 130 global consultancy and auditing projects

Second and third-party pharmaceutical support services

NSF provides a comprehensive range of pharmaceutical support services, including consulting, auditing, training and regulatory compliance. The company helps clients address industry challenges and public health and safety concerns, as well as meet the stringent requirements of the pharmaceutical industry.

NSF is recognised by industry experts as a partner for clinical services, regulatory compliance consulting, training and auditing.

Educational opportunities for pharmaceutical industry professionals

NSF International offers an extensive range of professional pharmaceutical training courses, which help clients with continuing professional development (CPD) for the pharmaceutical industry.

The courses cover many subjects and are designed to help professionals prepare for the next challenge by improving competitiveness and building knowledge.

Courses are aimed to improve operational excellence and competitive edge. They can be brought on-site and customised to meet client requirements.

Courses topics offered annually include:

  • Good manufacturing practice (GMP), including clinical trials
  • Pharmaceutical auditor
  • Sterile products manufacture
  • Quality risk management
  • Human error prevention
  • Changing GMP behaviours
  • Data integrity
  • Leadership development coaching
  • Corrective and preventative action (CAPA) system assessment training

The company also works alongside the University of Strathclyde to provide a qualified person (QP) training programme. The course is also approved by the Royal School of Chemistry.

Audits, assessments and certification

Separate from its training and consultancy work, NSF International helps clients reach a standard of excellence by providing a series of audits, assessments and certifications.

Its auditing and assessment offerings include pharmaceutical data integrity assessments, human error prevention, pharmaceutical auditing of third parties and suppliers, due diligence audits and auditor certification, excipient current good manufacturing practice (cGMP) certification and CAPA system assessment.

Remediation consultancy services

NSF International’s remediation consultancy services are designed to strengthen your business by managing warning letters, consent decrees, import alert notifications, product de-listings from the World Health Organisation (WHO) and removal of production and marketing licences in the EU.

Quality system optimisation and regulation readiness inspection

NSF International helps manage clients’ pharmaceutical quality system (PQS) to ensure optimal product quality and consistency.

The company aims to either simplify an existing PQS or develop and implement a new competitive system to help benchmark best industry practice.

NSF International‘s pharmaceutical regulatory inspection readiness and mock inspections service helps ensure pharmaceutical regulatory guidelines are met in preparation for US Food and Drug Administration (FDA), EU and WHO inspections.

About NSF International

NSF International’s team of former EU and FDA officials allows the company to offer global regulatory expertise with industry best practices to help clients achieve an effective PQS. NSF International supports the development, manufacturing and marketing of products and has a proven record of success.

Consulting, Auditing, and Assessments

NSF'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.

Remediation / Quality Systems Compliance

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

Training and Education

NSF International provides high-quality training and education, helping to develop an individual's career progression (including becoming a qualified person), training groups of staff on-site to understand changes in procedures and regulations, and helping to bring culture change within an entire organisation. NSF has the skills and programmes to meet your needs.

Data Integrity: A Closer Look

Data integrity continues to be a hot topic impacting the pharma/biotech industry, and the trend has been growing since 2010.

Addressing the Issue of Ageing Facilities

Executive director of pharma biotech at NSF International Nicholas Markel talks about the relatively new issue of ageing facilities, including what the issue is and how to diagnose and address it.

General Safety and Performance Requirements

The heart of the European Union (EU) regulation of in vitro diagnostic medical devices (IVDs) lies in allowing market access to IVDs that offer clinical benefit, and are safe to the patient, the user of the IVD and others (such as service technicians).

Journal 2019, Issue 44

Risk management across a global supply chain has never been a stronger factor in assuring economic success than it is now.

Advantages of Excipient GMP Certification

Making a case for good manufacturing practice (GMP) certification of an excipient manufacturer should be a straightforward exercise since the benefits appear so clear cut and regulatory guidance in the EU underscores the value of certification.

Black Friday Special Training Offers from NSF

Get 50% off NSF’s pharma and medical devices eLearning, £100 off selected one-day courses and £300 off our Responsible Person and Good Distribution Practice course.

September 2019 Courses

Spaces for NSF’s September courses are filling fast, so book now to secure a place and do not forget to take advantage of the company’s multi-delegate saving opportunities, in addition to NHS staff, regulator and charity discounts.

Learn About the GMP Standard for OTC Drug Manufacture

Do you manufacture over-the-counter (OTC) drugs for the US market? In this 30-minute NSF webinar, you will learn about the standard development process, key stakeholders, structure and main elements of the NSF/ANSI 455-4-2018 standard.

Visit NSF at Making Pharmaceuticals

There is not long to go until Making Pharmaceuticals. Are you attending? Make sure you join NSF for a coffee and a chat at stand 216.

NSF International Updates Pharma App

NSF International announces new updates for its pharma app, which is available on Apple’s App Store and Android’s Google Play.

New Interactive Webinar by NSF

NSF Health Sciences vice-president Martin Lush wants your input to this limited-place 30-minute webinar.

Regulatory Affairs for QA and QPs Workshops

One of the primary roles for Qualified Persons (QP) and other quality professionals is to make sure that the products released for sale are in compliance with the requirements of the marketing authorisation (MA) for that product.

Webinar: Reckoning With Risk

From the moment we get out of bed in the morning to when we return at night, we all take risks. Some big, others small. Some consciously, others less so. There is no such thing as zero risk.

NSF to Attend PDA Europe Conference in Seville, Spain

NSF’s executive director and ex-inspector at the medicines and healthcare products regulatory agency (MHRA) Rachel Carmichael will be speaking at the Outsourcing and Supply Chain PDA Europe conference this November in Seville, Spain.

NSF Launches Further Qualified Person Training in 2019

What does the future hold for the qualified person (QP) post-Brexit? There has been much debate on this matter. We do know that all EU centralised marketing authorisations must be held by a legal entity within the EU and that QP certification and pharmacovigilance (PV) need to occur in the EU. 

NSF subsidiary withdraws designation application for European IVD and MDR

NSF International’s medical devices programme in Europe is shifting senior leadership roles and responsibilities after a subsidiary of the global public health organisation withdrew its notified body designation application for European in-vitro diagnostic (IVD) and medical device regulations (MDR).

NSF Releases Two New Pharma eLearning Sessions

NSF International provides a comprehensive range of support services for the pharmaceutical industry covering consulting, training, auditing, remediation, quality systems and regulatory guidance on a global basis.

Upcoming Pharmaceutical Courses from NSF

NSF has announced a wide range of upcoming courses related to the pharmaceutical industry. Make sure you remember to take advantage of any discounts you could be entitled to. Get in touch if you're interested in bringing any of this training on-site.

Upcoming Pharmaceutical Courses in June and July by NSF

NSF has announced a range of upcoming courses in June and July. Make sure you remember to take advantage of any discounts you could be entitled to. Make an enquiry if you are interested in bringing any of this training on-site.

Webinar: Conquering the Chaos

There’s an old saying, 'Proper planning prevents poor performance', and another adage tells us to 'Begin with the end in mind'. Well, what happens when you don’t know what the end looks like? How can you plan for your career, your workplace or your business in a world of chaos and uncertainty? Well, listen in for some practical tips!

NSF Announces New Workshops

NSF has announced the release of a new collection of pharmaceutical workshops for the 2017/2018 period.

Orphan Drugs and Rare Pediatric Disease

The 21st Century Cures Act stemmed from a political spotlight on two girls that could not get treatment for their rare diseases, as presented by Senator Upton in his opening statement at the Legislative Hearing on 21st Century Cures Act.

Patient-Focused Drug Development

Enacted into law December of 2016, the 21st Century Cures Act is an initiative to expedite and enhance the process of discovery, development, and delivery for disease treatments.

NSF International Acquires IPEA

NSF International has acquired the International Pharmaceutical Excipients Council of the Americas’ (IPEC-Americas) auditing subsidiary, IPEA.

NSF Releases White Paper

NSF has released a white paper entitled 'Does your Pharmaceutical Quality System Improve your Competitive Edge?'.

NSF International Acquires the INASSA Group LLC, a Peruvian Leader in Analytical Testing, Certification, Inspection and Training for the Seafood / Fishing, Food and Pharmaceutical / Medical Industries

NSF International, an independent global public health and safety organization which develops standards, and tests and certifies products for the food, water and health sciences industries, has acquired the INASSA Group of Lima, Peru, which is comprised of three segments: technical analysis, laboratory and sanitation.

NSF International First to Offer High Quality Secondary Reference Standards to India’s Growing Pharmaceutical Sector at Lower Cost

NSF International, an independent global public health and safety organization which develops standards, and tests and certifies products for the pharmaceutical, dietary supplement, food, water, and consumer products industries, is the first to offer Secondary Reference Standards in India, helping meet the growing India pharmaceutical sectors' need for high quality, economical alternatives to pharmacopoeia standards.

NSF International, Pharmaceutical Services

The Georgian House

22/24 West End

Kirkbymoorside, York

YO62 6AF

North Yorkshire

United Kingdom

+44 1751 432 999 +44 1751 432 450
NSF India Office

Plot 127, Sector 44, 2nd floor

Gurugram

Haryana, 122 002

India