Quality & Compliance For Continuous Improvement

Pharmaceutical Quality; GxP Training, Consulting and Auditing Services

Offering You Practical Solutions With Outstanding Results

Pharmaceutical and biotech companies are challenged by more complex supply chains, ever-changing regulations and a volatile and uncertain global environment where patients and healthcare providers expect affordable, high quality medicines.

At NSF we have over 30 years’ industry experience. We have all stood in your shoes and understand your challenges. Scroll down to learn more about the services we provide.

About NSF: Global Experts for Pharmaceutical Consulting, Auditing and Training

Our Services

Martin Lush shares his six-step checklist on how to increase your training budget in a world of scarcity and improve your business for the long term. (pp – 3-5)

John Johnson explains how to manage the risks associated with outsourcing. The article includes information on priorities, costs and key messages when contracting out a manufacturing process. (pp – 6-7)

Regulatory affairs expert Marinka Tellier reviews FDA’s Sentinel Initiative which is aimed at modernizing pharmacovigilance, providing insight into the five-year strategic plan and potential future benefits. (pp – 8-9)

This Q&A with NSF’s medical device expert Kim Trautman looks at the key changes occurring with the EU MDR. She explores how companies can prepare for the May 2020 deadline.

(pp – 18-19)

Get In Touch

Have questions or want more information on our services? Contact our team at pharmamail@nsf.org or visit www.nsfpharma.org.

Europe: The Georgian House, 22-24 West End, Kirkbymoorside, York, YO62 6AF, UK

USA: 789 N Dixboro Rd, Ann Arbor, MI 48105, USA

China: 8th Floor / 9th Floor, Building 1, No. 760, Xinjun Ring Road, Shanghai

Contact us if you want to be proactive and drive improvements, or if you have some specific regulatory or technical issues and need guidance. We offer the following services:

Development and implementation of cost-effective, compliant pharmaceutical quality systems
Advice on design, qualification and validation of new facilities, equipment, computerized systems and processes
Legal and regulatory issue guidance
Assistance with responses to regulatory inspection reports
Simplification of quality processes, SOPs and batch records
Advice on specific technical problems
Benchmarking against best industry practices – beyond the regulations

Learn more about our range of services.

Standards

NSF perform audits against Good Manufacturing Practice, Good Distribution Practice, Good Pharmacovigilance Practice and Good Clinical Practice international regulations.

Audits

We audit active pharmaceutical ingredients, excipients, medicinal product manufacturers, distributors, investigational medicinal product manufacturers, QC laboratories, affiliates, contract manufacturers, computerized systems and more.

Our processes can be tailored to your specific needs, including:

Due diligence audits
Compliance auditing – assessment of activities against standards
Inspection readiness audits
Auditing your supplier
Audits of your internal audit processes

Outputs can include efficiently reaching compliance.

Learn more about our range of services.

You are only as good as your people. We offer education programs that will change behaviors, improve performance and “future proof” your organization. Any of our European public courses can be tailored and run on-site globally. Examples of education offered annually include:

Good manufacturing practice, including clinical trials
Regulatory issues and regulatory affairs
Auditing and self-inspections (Including a CQI and IRCA certified course)
Sterile and biotech products manufacture
Quality risk management
Human error prevention
Changing GMP behaviors
Data integrity
Process validation
Deviation and CAPA Management
Responsible person and Good Distribution Practice

We also work alongside the University of Strathclyde to provide a Royal Society of Chemistry Approved Qualified Person training program.

Learn more about our pharmaceutical training.

Looking for an update on the health sciences industry? NSF’s Health Sciences Journal provides you with the latest industry insights on current hot topics as well as essential tips, advice and knowledge from our team of experts which includes former regulatory agency staff and experienced industry professionals. You will also receive the latest global regulatory updates and details of our training and education program.

View our latest Journal.

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