NSF International, Pharma Biotech Consulting, Auditing, Testing, Training and Regulatory Support

NSF Health Science

NSF International provides an extensive range of quality services to the pharmaceutical, biotech and medical device industries. NSF’s offerings include certification, testing, training, consulting, auditing and regulatory support services, bringing quality and safety to your door.

Additionally, NSF supplies secondary reference standards globally, traceable to both United States Pharmacopeial Convention (USP) and European Pharmacopoeia (EP).

Second and third-party pharmaceutical support services

NSF provides a comprehensive range of second and third-party pharmaceutical support services covering consulting, auditing, testing, training and regulatory compliance. Recent public health concerns and challenges have underscored regulators’ proactive pursuit of compliance in the pharmaceuticals industry. The market need for outsourced clinical, regulatory and compliance consulting; training; auditing and testing has been recognized by pharma industry experts.

Regulatory consulting services for pharmaceutical and biotech companies

NSF provides consulting across a variety of therapeutic areas, product types and regulatory specialties. Our services include:

  • Regulatory consultation: target product profiles, regulatory strategy, orphan drugs, unique and combination products (due diligence, regulatory pathways) and global BLA/NDA/MAA/CA strategy: response to agency questions
  • Regulatory submissions: orphan drug applications, fast-track designation, IND, ANDA, NDA and BLA filings as well as post-marketing submission support (PAS, CBE-30, BLA, REMS reports)
  • Meeting preparation: pre-IND, end of Phase II (EOP2), pre-BLA and advisory committee
  • Clinical study design and evaluation: patient population identification, study site evaluation, endpoint selection, statistical analysis plans, study reports and manuscripts and publication development
  • Global regulatory filings

OTC pharmaceutical GMP registration

NSF International’s over-the-counter (OTC) pharmaceutical GMP protocol is a pharmaceutical quality management registration system for OTC drug manufacturers, wholesalers and retail pharmacies.

GMPs establish requirements for the methods, facilities and controls used to manufacture, process and package OTCs to make sure they are safe to use and match the ingredients and strengths listed on the label.

The protocol sets requirements in the areas of personnel, building and facility maintenance, equipment, production / process controls, holding / distribution, laboratory controls, recordkeeping, packaging and labeling.

GLP and GMP contract laboratories

NSF operates as a GLP and GMP contract laboratory, which are FDA registered and DEA licensed for pharmaceutical testing.

NSF provides analytical testing, consulting, R&D, toxicology risk assessment, clinical trial, registration and commercialization services to the pharmaceutical and biotech industries.

Our mission: to play an integral role in the development of pharmaceuticals to improve the lives of patients and their families. To develop and educate the next generation of pharmaceutical researchers, and to impart to them the importance of why we do what we do.

Extractables and leachables testing

NSF offers an extensive range of testing for extractables and leachables. Key E&L services that NSF offers:

  • Method development and validation
  • Controlled extractions under GMP and PQRI guidance
  • Identification of major extractables by GC/MS, LC/MS, ICP/MS and FTIR
  • Determination of analytical evaluation threshold (AET)
  • Monitoring of leachables on drug product stability

Pharmaceutical CPD training courses

NSF International offers an extensive range of professional pharmaceutical training courses as continuing professional development (CPD) for the pharmaceutical industry. Courses cover many subjects and are designed to help you prepare for the next challenge, improve your competitiveness and build your knowledge base.

The course helps you understand, and communicate to your colleagues, causes, risks and cGMP requirements. Courses are aimed at improving operational excellence and competitive edge. Some courses offered annually include:

  • Human error: causes and prevention
  • EU GMP and inspection readiness
  • The role of the qualified person
  • Pharmaceutical auditor training
  • EU GMP requirements for clinical supplies manufacture
  • Satisfying EU GMP requirements for sterile products manufacture
  • Engineering aspects of GMP
  • Pharmaceutical packaging GMP

Medical device audits, testing, training and consulting

Medical device organizations have been put under the spotlight recently due to public health concerns. The industry is scrutinized by regulators across the globe.

NSF’s consulting, testing, auditing and education services address today’s highly complex, high-risk medical products across the entire lifecycle. NSF assembled a specialist team in the regulatory, scientific, analytical testing and compliance field that understands the regulatory and safety requirements needed to bring medical products onto the market — and sustain them.

Core regulatory affairs services for medical devices

NSF offers a wide range of regulatory consulting services, including:

  • Regulatory consultation: product classification, regulatory strategy, unique and combination products, due diligence and emerging regulatory issues
  • Regulatory submissions: IDE, 510(k), PMA, 513(g), European CE marking in Class III medical devices, and post-marketing submission support (PMA supplements, 510(k)s for device changes, annual reports, and post-market studies)
  • FDA and European agency interactions: pre-510(k) and pre-IDE meetings and competent authority scientific briefings, advisory panel preparation and support, dispute resolution and administrative appeal
  • Clinical study design and evaluation: patient population identification, study site evaluation, endpoint selection, statistical analysis plans, study reports and manuscripts and publication development
  • Global regulatory filings

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Press Release

Lynne Byers and David Waddington Join NSF International’s Pharma Biotech Service in Europe

NSF International has appointed Lynne Byers as executive director and David Waddington as director of its pharmaceutical biotech services in Europe.

Product and Services
White Papers

What Would Steve Jobs Tell the Pharma Biotech Industry?

Whether or not you are a fan of the man and his products, he was successful and different, and his methods have merit. 

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NSF International, Pharma Biotech

NSF International, Pharma Biotech Images

Press Release

7 November 2017

NSF International has appointed Lynne Byers as executive director and David Waddington as director of its pharmaceutical biotech services in Europe.

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20 September 2017

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

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12 September 2017

To celebrate its 40th anniversary, the Pharmaceutical Quality Group (PQG) is holding an anniversary dinner and a three-day meeting at the Hilton Hotel in Milton Keynes, UK.

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13 August 2017

NSF’s pharma biotech experts are now providing services to India’s pharmaceutical industry from its Gurugram office.

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18 July 2017

US Food and Drug Administration (FDA) regulations protect the health, safety, and overall quality of products so they do not adversely affect consumers. That is also why current good manufacturing practices (cGMP) are in place.

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5 June 2017

NSF Health Sciences has announced it will be hosting a two-part webinar to discuss the new label text guidelines for pharmaceticals.

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28 May 2017

NSF International has launched a new app designed for pharmaceutical biotech industry executives.

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24 May 2017

NSF International has released a list of upcoming courses for June and July.

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18 May 2017

NSF International's pharma biotech team has announced it will be present at the 2nd PDA Europe Annual Meeting in Berlin.

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25 April 2017

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.

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31 March 2017

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.

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16 March 2017

NSF International is offering training for lead auditors of quality management systems (QMS) based on both ISO 13485:2016 and international Medical Device Single Audit Plan (MDSAP) requirements.

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7 February 2017

NSF International is partnering with the Indian Drug Manufacturers' Association (IDMA) to offer a customised, five-module pharmaceutical quality management (PQM) education programme in Bangalore, India.

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30 January 2017

NSF International has announced the retirement of Bob Pietrowski PhD, a 40-year veteran of the pharmaceutical and medical device industries who has served as vice-president of NSF International's Global Health Sciences Division since 2013. He is being replaced by Martin Lush.

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3 October 2016

NSF International has announced a new partnership with non-profit organization Textile Exchange to boost sustainability in the textile industry.

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7 September 2016

NSF-GFTC will now be called NSF International after changing its name.

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8 April 2015

NSF International has published the first American National Standard for pharmaceutical excipients, NSF/IPEC/ANSI 363: Good Manufacturing Practices (GMP) for Pharmaceutical Excipients.

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24 February 2015

NSF International will be attending the 54th Annual Meeting and ToxExpo from 22-26 March at San Diego Convention Center.

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9 February 2014

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

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4 February 2014

NSF International has integrated subsidiary companies NSF Becker & Associates, NSF-DBA and NSF Pharmalytica, as well as its existing Dietary Supplement Program, into one unified Health Sciences Division.

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17 December 2013

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

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5 June 2013

NSF International, an independent global public health organization that develops high quality reference standards, now has Atorvastatin Calcium Reference Standard Kits, which are traceable to official US (USP) and European pharmacopeial (EP) standards.

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5 June 2013

The International Pharmaceutical Excipients Council of the Americas (IPEC-Americas) - an international non-profit comprised of pharmaceutical and excipient manufacturers and distributors - has approved the sale of its IPEA auditing subsidiary to NSF International.

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5 June 2013

NSF Becker & Associates Consulting, part of global independent public health organization NSF International, has launched a new program to assist companies in achieving 360 operational compliance to the commercial practices of the life science industry.

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23 May 2013

NSF Health Science has release five white papers on 510(k) requirements for extractables and leachables; analytical challenges for leachables; FDA excipient regulations; quality in the US pharma industry and new European regulations for medical devices.

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28 January 2013

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.

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23 January 2013

The US Food and Drug Administration (FDA) requires extractables and leachables testing for many medical devices.

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27 November 2012

NSF International, a global independent public health organization that writes standards, and tests and certifies products for the health sciences, water, food, and consumer goods industries, has welcomed three leading pharmaceutical and biotech experts to its Health Sciences Division.

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27 August 2012

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.

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Regional Offices

NSF International, Pharma Biotech
NSF International, Pharma Biotech

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

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