NSF Health Sciences Journal: Time to Rethink - Issue 47, 2020
Work with our team of former regulators and industry experts to audit your quality systems, conduct clinical trials, prepare for inspections and file regulatory submissions in order to bring your products to market.
Clinical Trial Support
NSF provides efficient, effective clinical trial support and product development strategy. We help you optimize time and cost throughout the process while maintaining the highest levels of quality, integrity and scientific excellence.
Audits and inspections assess the capability of an organization to follow the relevant regulations, requirements and guidances.
Preparing for GxP Inspections
Identify key risks and follow expert mitigation strategies prior to your GMP inspection. We'll help you prioritize and address concerns, creating perpetual inspection readiness.
Regulatory Strategy and Submissions
Receive customized regulatory pathways to bring innovative pharmaceuticals, biologics, gene and cell therapies and combination products to market efficiently.
NSF Now Offering Live Instructor-Led Virtual Pharmaceutical and Medical Devices Training
May 19, 2020
To complement its face-to-face offering, NSF now offers traditional classroom courses as virtual instructor-led training to support your professional development. Courses are delivered via a combination of live instructor-led virtual classrooms and self-paced online learning. NSF’s coaches are on hand to guide participants through the interactive sessions which also include pre- and post-course activities.
NSF International Announces Updated GMP Standard for Pharmaceutical Excipients
April 16, 2020
The NSF/IPEC/ANSI 363-2019: Good Manufacturing Practices (GMP) for Pharmaceutical Excipients standard has been revised to align more closely with the structure of ISO 9001:2015 (EN) Quality Management Systems – Requirements.
Brexit Implications for the UK Pharmaceutical Industry
January 3, 2018
The only thing that is certain following the UK’s momentous decision to leave the European Union (EU), so called Brexit, is that the pharmaceutical industry, as all others, is facing at least two, and probably many more, years of unprecedented uncertainty.
OEHHA Issues Proposed NSRLs for Three Disinfection By-Products
August 11, 2020
On May 22, the California Office of Environmental Health Hazard Assessment (OEHHA), which assesses health risks of environmental contaminants in products sold in California, issued three notices of proposed rulemaking (NPRs) establishing proposed no significant risk levels (NSRLs) for three water disinfection by-products : trichloroacetic acid, dibromoacetic acid and dichloroacetic acid; also known as haloacetic acids. These NPRs were open for comment until July 7. OEHHA is now reviewing the comments and will then issue a final rule.