We help sponsors and health authorities streamline submissions, adopt and implement global regulatory data standards, and leverage cloud‑based platforms to improve data quality and accelerate patient access to medical products—backed by hands-on expertise in industry and FDA.
WEBSITE IS UNDER CONSTRUCTION - CHECK BACK SOON
WEBSITE IS UNDER CONSTRUCTION - CHECK BACK SOON
Regulatory Strategy & PolicyTailored informatics roadmaps and specialized guidance on regulatory requirements—ensuring your submissions are compliant, efficient, and strategically aligned
Data Standards AdvisoryExpert recommendations on data standards; best practice implementation approaches; and governance frameworks to ensure data consistency and regulatory readiness
Cloud Submission ConsultingDesign, pilot and implement cloud platform use cases-such as standardized clinical protocols, study data validation, labeling, RWD, and regulator-to-sponsor collaboration- while advising on secure, zero‑trust workflows and regulatory environments for seamless sponsor–regulator collaboration.
Global Collaboration AdvisoryDesign and lead international working groups, stakeholder-engagement strategies, and cross agency alignment plans-uniting sponsors, regulators, and standards organizations around shared objectives.
Data Standards AdvisoryExpert recommendations on data standards; best practice implementation approaches; and governance frameworks to ensure data consistency and regulatory readiness
Cloud Submission ConsultingDesign, pilot and implement cloud platform use cases-such as standardized clinical protocols, study data validation, labeling, RWD, and regulator-to-sponsor collaboration- while advising on secure, zero‑trust workflows and regulatory environments for seamless sponsor–regulator collaboration.
Global Collaboration AdvisoryDesign and lead international working groups, stakeholder-engagement strategies, and cross agency alignment plans-uniting sponsors, regulators, and standards organizations around shared objectives.
Services at a Glance
A consultancy led by Ron Fitzmartin, PhD, MBA, a regulatory science and pharmaceutical veteran with more than 25 years of experience in clinical research, data standards strategy, and digital submission innovation. We partner with pharmaceutical sponsors, government agencies, and standards organizations to streamline complex regulatory processes.