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.
Scientists working on computer and microscope in laboratory

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.

Regulatory Services

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.

Regulatory Strategy

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.

Regulatory Submissions

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

Market Approvals

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’s Health Sciences Team Joins Fight to Save Lives With More Ventilators

April 23, 2020

NSF’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.

March 2023 Pharma News Update

March 1, 2023

The U.S. NIST has developed a framework to better manage risks to individuals, organizations and society associated with artificial intelligence (AI).

March 2023 Medical Device and IVD News Update

March 1, 2023

Welcome to our March Medical Device and IVD news update. Every month we'll bring you the latest medical device and IVD industry news, useful articles and resources, expert advice, training, and events for your calendar.