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