NSF Pharma Biotech Consulting

Partnering with you to provide world-class regulatory and compliance consulting, auditing and pharmaceutical training on a global basis.

NSF Health Sciences Pharma Biotech Consulting partners with you to provide world-class regulatory and compliance consulting, pharmaceutical auditing, pharmaceutical training and clinical testing on a global basis.

NSF Health Sciences Pharma Biotech Consulting provides a comprehensive range of independent, third-party pharmaceutical and biotech support services covering consulting, training, auditing, testing and regulatory guidance for the pharmaceutical industry. These services are delivered by some of the most knowledgeable experts in their fields. Our unique combination of former regulatory agency staff and experienced industry professionals will assist you to achieve and maintain compliant, future-proof Quality Management Systems (QMS), develop your staff at all levels to maximize their contribution to the business and, overall, help you to improve the competitive edge of your company in an increasingly complex and challenging marketplace. In short, we are here to help get your products to market.

We help you enhance and embed the right culture throughout your organization. The right people. The right solution. The first time.

Our ‘Not for Profit’ status means we act in your long-term best interest based on good science, expert experience and common sense. We care about you, our clients, which is why over 87% come back for more.

Our Specific Services: Providing you with Solutions across the Product Life Cycle

  • Customized education programs that will change behaviors, improve performance and ‘future proof’ your organization.  You are only as good as your people!
  • Qualified Person Education. More people have become ‘QPs’ in Europe through our QP training program than any other training provider
  • Remediation consultancy. Helping you successfully manage Warning Letters, Consent Decrees, Import Alert Notifications, WHO ‘de listing’ and removal of manufacturing and marketing licenses in the EU. With us you will emerge stronger and fitter
  • Quality System simplification, implementation, compliance assessment and benchmarking against best industry practice. We want 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’. We will help you to succeed in your next FDA, EU or WHO Inspection
  • Pharmaceutical Data integrity assessments. Let us 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
  • Pharmaceutical Auditing of Third Parties and Suppliers. Let us help you to sleep easy at night!
  • Due Diligence Audits. We will help you spend your money wisely
  • Auditor Certification. We will independently ‘certify’ your GMP auditors so you can be confident with their findings
  • Analytical Testing – Our pharmaceutical testing provides accurate, reliable, timely and cost-efficient contract analytical solutions. For your peace of mind, our laboratories operate under full GLP and GMP compliance

More on our Pharmaceutical Training & Education

NSF Pharma Biotech Consulting is known all over the world for its high quality pharmaceutical training and education, including our QP training. Whether you are looking to send one of your people to an open course for career progression (including becoming a Qualified Person or senior quality professional), to train a group of staff in house in changes in procedures and regulations, or to bring about culture change within an entire organization, our pharmaceutical training programs have you covered.

More on our Pharmaceutical Auditing

Pharmaceutical and biotech companies all over the world trust us to perform comprehensive audits to the latest GMP regulations and expectations, and to work with them in the development, implementation and verification of corrective action plans (CAPs) that are comprehensive, compliant and sustainable. We can assess any type of activity against all major international regulatory and GMP standards, including EU, USA, Canada, Australia, WHO and more. Rather than simply telling you where you fail to comply, we provide essential, pragmatic advice on how to achieve compliance in a cost-effective way.  

More on our Pharmaceutical Consulting 

Our unique team of ex-regulatory agency inspectors and industry professionals enables us to provide pharmaceutical consulting that is authoritative and respected by major pharma companies and regulatory agencies around the globe. We have subject matter experts in a broad range of pharmaceutical product types who provide expert advice across the product lifecycle, from development through registration and to technical transfer, manufacture and eventual discontinuation.

More on Regulatory / Clinical Support

NSF Pharma Biotech offers expert FDA regulatory/clinical support and consulting services to all sizes of pharmaceutical and biotech companies, investment firms, and regulatory or litigation counsel who need experts to interpret or navigate the intricacies of FDA pharmaceutical and biotechnology regulations.

Why choose NSF Pharma Biotech Consulting?

Our clients tell us we’re different, which is why they stay with us.

  • Our people are the best; experienced and pragmatic. They have been in your shoes. They understand your world and they care, a lot
  • We treat you as partners, not clients. We work with you and stick with you, no matter what
  • We want to make your life easier and your business better. We will tell you what you must STOP doing to succeed
  • We believe in preparing you for the future, not for a world that no longer exists
  • We will help you simplify, not complicate
  • With offices in all five continents we understand the languages and cultures better than most

We help you enhance and embed the right culture throughout your organization. The right people. The right solution. The first time.

For more information about NSF Pharma Biotech Consulting and our services, visit www.nsfpharmabiotech.org, contact us at pharmamail@nsf.org or call +44 1751 432 999.

 

 

 

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Experts

  • Rachel Carmichael, MSc

    Executive Director, NSF Health Sciences Pharma Biotech Contact Expert

    Rachel Susan Carmichael has over 20 years’ experience of pharmaceutical manufacture, control and quality management including nearly 11 years as a GMDP Inspector for the UK Competent Authority, the MHRA.

  • John Johnson, FRSC, CChem, MIQA

    Vice President, NSF Health Sciences Pharma Biotech Contact Expert

    John Johnson is passionate about helping organizations foresee and overcome the barriers to sustainable long-term growth. He brings 28 years’ experience across a range of companies in the pharmaceutical and healthcare industry.

  • Peter Gough, Hon DSc, MSc, CSci, CChem, FRSC, FCQI, CQP

    Executive Director, NSF Health Sciences Pharma Biotech Contact Expert

    A chemist with a master’s degree in analytical chemistry, Peter Gough has nearly 40 years’ experience of pharmaceutical manufacture, control and quality management.

  • Mike Halliday, MRPharmS, PGDip

    Executive Vice President, NSF Health Sciences Pharma Biotech Contact Expert

    Mike has extensive pharmaceutical manufacturing management and QA experience, gained over 20 years working for three major international pharmaceutical manufacturers.

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Contact details

Phone

+ 44 (0) 1751 432 999

Fax

+ 44 (0) 1751 432 450

NSF Pharma Biotech Consulting
The Georgian House, 22/24 west End
YO62 6AF, Kirkbymoorside
United Kingdom

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