Establishes Complete Range of Clinical and Regulatory Services for Life Science Companies
WALTHAM, Mass.– September 10, 2024 – Danforth Advisors, LLC, today announced the acquisition of Advyzom, LLC, a leading regulatory affairs consultancy, creating a single, comprehensive resource for life science companies to access the expertise required on the path to proof-of-concept, regulatory approval, and market entry.
Danforth’s clinical and regulatory bench now spans experts across preclinical and medical advisory, clinical development operations, regulatory strategy, FDA liaisons and submissions, medical writing, and clinical and CMC outsourcing. By assembling the critical functions of asset development under one roof, Danforth maximizes operational efficiency for life science companies and applies the benefit of deep institutional knowledge across key roles.
Founded in 2011, Advyzom comprises approximately 30 specialists with backgrounds in biotechnology and big pharma, providing expertise in global regulatory strategy, FDA relationships as US agents, document publishing, regulatory submissions, and medical writing. The team serves as a primary interface to health authorities and has led or supported the achievement of hundreds of regulatory milestones for clients, including INDs, NDA/BLA filings and approvals, and numerous FDA designations to expedite development and approval. Founder and CEO Cindy Dinella will continue in her leadership role.
“Advyzom brings top talent and an exceptional track record in regulatory strategy, timely execution, and positive working relationships with health authorities – all critical to achieving clients’ drug development and commercialization objectives. We now have a fully integrated suite of clinical and regulatory services that can adapt to every stage of development,” said Chris Connors, CEO of Danforth Advisors. “More broadly, this latest acquisition advances our vision to be an agile foundation for life science companies – providing the variable teams and skill sets they need to run the business, develop assets, and launch products.”
“We are privileged to work with pioneering innovators to help much-needed treatments reach patients, and in Danforth we found a team that shares our passion for this cause,” said Dr. Dinella. “We are excited for the opportunity to partner with more life science companies who require thoughtful leaders and hands-on collaborators to navigate the regulatory landscape across the development journey.”
Advyzom is the fourth organization to join Danforth, following the acquisitions of BW Health Group in 2024, Elite BioPharma Consulting in 2023, and Argot Partners in 2022. In December 2021, Danforth announced an investment by Avesi Partners, LLC, to accelerate plans to meet an ever-broadening scope of strategic and operational needs for life science companies.
About Advyzom
Advyzom is a leading boutique consulting company specializing in highly strategic regulatory and development advice and services for clients in the pharmaceutical and healthcare industries. The company is headquartered in New Jersey and supports the development programs of clients at all stages as a virtual or embedded extension of their teams. Additional information is available at www.advyzom.com.
About Danforth Advisors
Danforth is the life science industry’s trusted partner for strategic and operational support across corporate, clinical, and commercial functions. The company advises and executes in the areas of finance and accounting, strategic communications, human resources, risk management, clinical and regulatory, and commercial readiness and launch. Founded in 2011, Danforth has partnered with more than 1,000 life science companies, private and public, across all stages of the corporate lifecycle. The company serves clients around the globe from its base in Waltham, Massachusetts and regional operations in New York, Pennsylvania, Maryland, California, and London.