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.