NSF Health Sciences, Pharma Biotech

Consulting, Auditing, Testing, Training and Regulatory Support

NSF Health Science

NSF International Health Sciences Division 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

Contact Details

NSF Health Sciences, Pharma Biotech
2001 Pennsylvania AVE NW Suite 950
20006
Washington
United States of America
+1 (202) 822 1850
+1 (202) 822 1859
uspharma@nsf.org
www.nsfpharmabiotech.org
Pharma Biotech Videos on NSF Health Sciences YouTube channel
Company Video: Human Error Reduction
Company Video: How to Achieve a Blame-Free Culture

Available White Papers

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Rules for Investigating Good Manufacturing Practice (GMP) Deviations in Sterile Processing 23 May 2017 When things go wrong, there are five non-negotiable processes that should be defined on your deviation investigation standards of practice (SOP): immediate engagement, gemba, triaging using a documented risk assessment, using the Klein process to determine potential root causes, and documenting in real time using an investigation worksheet.

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The Costs of Over-Complexity 16 May 2017 In this whitepaper, Martin Lush discusses the issue of over-complexity in the pharmaceutical industry.

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Want to Change Your Quality Culture? 30 March 2017 Despite lots of effort, most change initiatives fail because behaviour of the masses remains unchanged.

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Changing GMP Behaviours 18 October 2016 Most people are content to stick to tried and tested habits because it's easy. To encourage them to think and act in a new way (a difficult process for most), you have to provide motivation.

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Human Reliability Improvement: How to Reduce Documentation Errors 26 May 2016 We live in a world where we are surrounded by electronic data transmitting to every device imaginable yet we continue to experience documentation errors.

Company Videos