NSF International, Pharma Biotech Regulatory Support, Auditing and Training Services for Drug Manufacturers
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 2017, NSF International:
- Has provided services to Forbes’ top ten most reputable pharmaceutical companies and to the top 20 of Pharmaceutical Executive’s largest companies by revenue
- Held more than 30 residential courses and workshops and 50+ global on-site training courses
- Successfully ran 115 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 U.S. 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.
Products and Services
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.
Regulatory Strategy / Submissions
NSF International provides regulatory solutions and strategic input across a wide variety of therapeutic areas.
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.
Pharmaceutical Investigation and CAPA System Assessment and Training
Pharmaceutical failure investigations and corrective and preventive action (CAPA) system weaknesses are consistently among the top most frequently cited regulatory observations and the top finding in US Food and Drug Administration (FDA) warning letters.
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.
The Importance of Winning the Talent War and Investing in Education
NSF Pharma Biotech's CEO Martin Lush recently had a meeting with a CEO to help solve his company’s pain points.
What Does Poor Quality Cost?
'The cost of quality' is a simple statement and yet few companies in the pharmaceutical manufacturing industry are paying close enough attention to this concept.
Managing Change – There is No Time Like the Present
Organisational change can take on many guises. Most changes are planned and orchestrated by company management such as a plant expansion, an updated material requirements planning (MRP) system or a new incentive programme.
What Does Organisational Development Mean to You?
When NSF conducts research or support projects that seek a level of transformational change within a team or wider organisation, it applies its experience and expertise in the internationally recognisable current good manufacturing practice (cGMP) expectations.
Continued Process Verification
This white paper from NSF consultant Richard Kettlewell builds on an earlier white paper from Pete Gough, which introduced the regulatory expectations for Stage 3 of the process verification lifecycle.
NSF International’s pharma webinars are short, interactive sessions featuring its world-leading experts discussing topics of current concern.Read more
NSF has announced its new complimentary webinar, How to Install a Data Governance Process from Ground Zero'.Read more
NSF has announced it will be attending the IPEC Europe Excipients Forum in Malta.Read more
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.Read more
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.Read more
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).Read more
NSF International’s pharma biotech team will be exhibiting at CPhI Worldwide in Madrid, Spain this October.Read more
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.Read more
NSF will be exhibiting at the 2018 International Pharmaceutical Federation (FIP) World Congress in Glasgow, Scotland.Read more
NSF International has announced up-coming workshops in September, including topics such as incident management and human error prevention.Read more
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.Read more
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.Read more
NSF International has expanded its training offering and now provides pharma biotech eLearning.Read more
NSF has announced the dates for a variety of workshops taking place throughout May and June.Read more
NSF International has announced that there are still some spaces available on some of its upcoming pharmaceutical courses.Read more
NSF International has announced it will be exhibiting at the free-to-attend Making Pharmaceuticals Europe exhibition and conference.Read more
NSF International has announced it will be launching its pharmaceutical biotech e-learning programme in April 2018.Read more
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!Read more
NSF International has appointed Lynne Byers as executive director and David Waddington as director of its pharmaceutical biotech services in Europe.Read more
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.Read more
NSF’s pharma biotech experts are now providing services to India’s pharmaceutical industry from its Gurugram office.Read more
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.Read more
NSF Health Sciences has announced it will be hosting a two-part webinar to discuss the new label text guidelines for pharmaceticals.Read more
NSF International has launched a new app designed for pharmaceutical biotech industry executives.Read more
NSF International has released a list of upcoming courses for June and July.Read more
NSF International's pharma biotech team has announced it will be present at the 2nd PDA Europe Annual Meeting in Berlin.Read more
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.Read more
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.Read more
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.Read more
NSF International has announced a new partnership with non-profit organization Textile Exchange to boost sustainability in the textile industry.Read more
NSF-GFTC will now be called NSF International after changing its name.Read more
NSF International has published the first American National Standard for pharmaceutical excipients, NSF/IPEC/ANSI 363: Good Manufacturing Practices (GMP) for Pharmaceutical Excipients.Read more
NSF International will be attending the 54th Annual Meeting and ToxExpo from 22-26 March at San Diego Convention Center.Read more
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.Read more
NSF International Releases Atorvastatin Calcium Reference Standard Kits to Help Manufacturers in India Maintain the Highest Quality Standards
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.Read more
International Pharmaceutical Excipients Council of the Americas (IPEC-Americas) Approves Sale of Its IPEA Auditing Subsidiary to NSF International
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.Read more
NSF Becker & Associates Consulting Launches New 360 Corporate Compliance Program for the Life Sciences Industry
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.Read more
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.Read more
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.Read more
NSF Pharmalytica Expands Team to Meet Increased Demand for Extractables and Leachables Testing Required for 510(k) Compliance
The US Food and Drug Administration (FDA) requires extractables and leachables testing for many medical devices.Read more
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.Read more
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.Read more
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