Clinical Trial Support
Clinical Trial Product Development
We offer full contract research organization (CRO) services around the globe. Our leadership team has significant expertise in biomedical research. We design and conduct clinical trial research projects in many therapeutic indications, including wound healing, oncology, CNS, diabetes, cardiovascular disease, infectious diseases and more.
We also support all stages of product development, including clinical development and manufacturing, addressing pharmacovigilance issues as they arise.
We'll take your product through the entire approval process, from creating the regulatory approval strategy to conducting trials and writing the marketing approval application.
We offer comprehensive services in project management (Phase I-IV, BE/BA and PK/PD), regulatory affairs (FDA applications and meetings, applications to international health authorities and GxP compliance audits), clinical operations, adaptive study designs, statistical analysis, data management, medical monitoring, safety and pharmacovigilance and general consulting.
Our team of regulatory experts guides you from strategy to approvals. NSF works with regulatory authorities around the world, and we consider regulatory strategies at every step of the way to minimize timelines and improve the chances of success for your product registration. During your company's interactions with global regulatory agencies, our team of former FDA regulators provides superior representation, strategy and support.
Our submission strategies support early clinical development, product registration and late-phase trials in a global setting.
Backed by more than 20 years of industry experience, our team develops customized submission strategies designed to save you time and money. Receive expert guidance throughout your entire project lifecycle in order to meet regulatory standards for electronic submissions and prepare and deliver your application with confidence.
Our services also include:
- eCTD compliant FDA applications and submissions, including IND, IDE, 510(k), NDA, BLA, PMA, ANDA, orphan drug designation (ODD), de novo, compassionate use, emergency use authorization (EUA) and breakthrough therapy designation
- Regulatory strategy
- CMC expertise
- International regulatory agency submissions (CTA, IMPD, MA, CE, and others) and meetings
- GLP, GCP, GMP and GAP audits and certifications
- Clinical research results evaluation
- Clinical development plan, including statistical support
- Product development assessments
- Preclinical development plan
- Capture of preclinical study data to meet SEND requirements
We have helped obtain the following market approvals:
- 2020, De Novo Approval, EndeavorRX, ADHD
- 2020, 510(k) Approval, 1copyTM COVID-19 qPCR Multi Kit, Infectious Disease
- 2019, De Novo Approval, Weight Management aid, Gastroenterology
- 2019, 510(k) Approval, Vstrip H. pylori Antigen
- Rapid Test, Infectious Disease Diagnostic
- 2018, NDA Approval, Diacomit, Anticonvulsant
- 2017, 510(k) Approval, Gastroenterology/Urology
- 2016, PMA Approval, Dermal Regeneration Matrix, Wound Healing Device
- 2015, 510(k) Approval, BondEase Topical Skin Adhesive, Wound Healing Device
- 2010/2015, PMA Approval, INSTI HIV-1/HIV-2 Antibody Test Kit, Diagnostic
- 2013, NDA Approval, Brisdelle, Vasomotor Symptoms
- 2013, NDA Approval, Pediatric Inflammatory Disease
- 2012, NDA Approval, Pexeva, Depression & Anxiety
- 2012, NDA Approval, Pain Management
- 2012, PMA Approval, therascreen KRAS RGQ PCR Kit, Oncology Diagnostic
- 2011, PMA Approval, Solesta, Gastroenterology
- 2009, NDA Approval, QuitPak, Addiction
- 2008, NDA Approval, Amoxicillin PULSYS, Infectious Disease
- 2008, NDA Approval, Xenazine, Central Nervous System
- 2002, NDA Approval, Abilify, Schizophrenia
- 2001, NDA Approval, Adderall XR, ADHD
- 2001, PMA Approval, OrCel, Wound Healing Device
- 2001, PMA Approval, Remnant-Like Particles-Cholesterol (RLP-C) Assay, Diagnostic
- 1999, NDA Approval, Pletal, Cardiovascular
- 1998, NDA Approval, RAXAR, Infectious Disease
Ready to Begin the Process?
Contact us with questions or to receive a quote.
News and Events
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’s Health Sciences Team Joins Fight to Save Lives With More Ventilators
April 23, 2020
NSF International’s health sciences team is hands-on in the rapid ventilator manufacturing specification issued by the United Kingdom (UK) government. The UK National Health Service needs thousands more ventilators to help save lives as the country’s COVID-19 pandemic approaches its expected peak and ventilator capacity becomes a challenge.
Nine Potentially Harmful Stimulants Found in Weight Loss and Sports Supplements Listing Deterenol as Ingredient
March 23, 2021
GRMA Authorizes NSF International to Provide NSF/ANSI 455 GMP Certification Services to Members
March 22, 2021