Elevation Strategic Development, LLC

As a biomedical professional with more than 10 years of experience, Staci has a passion for driving diagnostic, medical device, and pharmaceutical innovations to market for the advancement of patient care. Staci is the Founder and President of Elevation Strategic Development, LLC, a clinical and regulatory affairs consulting company that services the diagnostics, medical device, and pharmaceutical industries. Working in both a CRO and Sponsor capacity, she has represented pharmaceutical and device companies as a liaison with FDA and other global regulatory agencies, such as the EMA. Her most recent therapeutic area of focus has been in oncology and immune-oncology, including therapeutic/diagnostic codevelopment, but she has experience in multiple therapeutic areas, as well as expert scientific knowledge of various methodologies and techniques. Staci holds a PhD in immunology and has maintained her Regulatory Affairs Certification (RAC) since 2015.

Elevation Strategic Development, LLC offers clinical and regulatory affairs consulting services for the diagnostic, medical device, and pharmaceutical industries. The company specializes in the design and implementation of regulatory and product development strategies to support initial market entry, as well as global expansion. All services are fully tailored to each client’s needs, ranging from large perspective planning to detailed implementation, including regulatory strategy, product development plans, clinical study design, regulatory communication meetings, quality system design, clinical trial monitoring, and medical writing. Please visit the company’s website (www.elevationsd.com) to learn more about the full suite of offerings. 

Website:

www.elevationsd.com

Personal LinkedIn:

www.linkedin.com/in/staci-j-kearney-phd-rac-86150120/

Company LinkedIn:

www.linkedin.com/company/elevation-strategic-development-llc/