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NSF Health Sciences Pharma Biotech Products

NSF Health Sciences Pharma Biotech

Pharma Training and Education NSF Pharma Biotech is known all over the world for the high quality of our training and education. Our programs have you covered 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 organisation.
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Compliance and Integrity Programs NSF commercial compliance support, OIG investigations, off-label promotion, false claims, anti-kickback, FCPA, CIA, aggregate spend, code of conduct.
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Analytical Testing NSF Health Sciences is a contract service provider to the pharmaceutical, biotechnology and medical device industries. Our GLP/GMP laboratories, located in Bristol, CT, are FDA registered and inspected and DEA licensed for Schedules I through V.

Our services include extractables and leachables testing for pharmaceutical packaging and medical devices, clinical and non-clinical bioanalysis, oligonucleotide analysis, biocompatibility testing and toxicological risk assessments.
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Pharmaceutical Audits 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.
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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.
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Regulatory Enforcement Action Support Regulatory inspections from authorities around the world may require pharma biotech companies to respond to specific enforcement actions. Helping you with regulatory compliance is the core of our expertise. Our team includes former US FDA and UK MHRA inspectors and experts with decades of experience helping companies develop strategic plans to address enforcement actions (FDA, MHRA, Health Canada, etc.)
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Pharma Quality Systems and Compliance Strong and robust quality systems are required for companies to consistently and reliably produce safe, high-quality products and services. Not addressing concerns highlighted in FDA 483's and FDA warning letters can potentially halt production or, worse, result in a recall, import bans, detention or product seizure, which can damage your organisation’s pipeline, financial well-being and reputation. With relentless, often subtle, changes to guidelines released by regulatory authorities around the world, it can be challenging to stay up to date.

With substantial experience in creating, implementing, reviewing and remediating quality systems for a variety of organisations, we at NSF Health Sciences Pharma Biotech are the premier source for assistance with any question or issue related to quality systems.
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Pharma Consulting NSF Health Sciences Pharma Biotech stays at the leading edge of regulatory and compliance issues for the pharmaceutical, biologics and biotech industries. Our unique team of ex-regulatory agency inspectors and industry professionals enables us to provide 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 can provide expert advice across the product lifecycle, from development through registration and to technical transfer, manufacture and eventual discontinuation.
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