established: 2013
history
Solaris was created to specifically meet the compliance needs of the growing biotherapeutic industry. This specialty includes support for cellular, tissue and gene-based therapy products under the requirements of the following regulations:
21 CFR Part 1271
21 CFR Part 820
21 CFR Part 210/211
21 CFR Part 11
American Association of Tissue Banks Standards for Tissue Banking
Our mission is to provide simple and flexible solutions for compliance. We believe that compliance systems should be formulated in a manner to facilitate business growth as well as to foster current or future organizational culture.
Our team prides ourselves in the ability to assimilate into organizational teams to best understand our clients business and cultural needs as they apply to compliance programs.
TIMELINE
2013 - BUSINESS ESTABLISHED WITH INTENT TO BRING A DIFFERENT CLIENT EXPERIENCE BASED ON DEFICIENCIES IN THE FIELD
2015 - BUSINESS EXPANSION INTO MEDICAL DEVICE MARKET/SUPPORT OF 510(k) SUBMISSIONS AND ISO COMPLIANCE.
2019 - REGULATORY EXTENSION INTO PRE IND, IND, AND BLA SUBMISSIONS
2023 - REPRESENTATIVE APPOINTMENT TO AMERICAN ASSOCIATION OF TISSUE BANKS (AATB), LIVING DONOR COUNCIL
our founder
Solaris SRB is led by Katie Laney, a Quality Assurance and Regulatory Affairs professional with 20 years of experience in the Life Sciences industry, including human tissue, biologics, and medical device compliance. Katie has a proven track record of providing solutions-oriented advisement to guide product development, research and commercialization efforts for a vast portfolio of innovative tissue, cellular and gene based therapeutic products.
With niche experience in the evolving regulatory and compliance landscape for Birth Tissue-based biotherapeutic products, Katie has led the charge in FDA pre-market regulatory activity in this area, including authoring of numerous pre-IND, IND and BLA submissions.
In addition to regulatory Subject Matter Expertise, Katie is also successful at establishing corporate compliance programs, GxP auditing, project management, and providing strategy/leadership for remediation efforts for small and large organizations.
Location
We are located in beautiful Miramar Beach Florida! Our business started in this area, and has multiple routes of travel if you need us to assist you in person!
495 Grand Blvd Suite 206
Miramar Beach FL 32550