Bridging Health-Matters, LLC Achivements

Achievements

9 NDAs (1 Orphan Drug)/CTDs; 20 INDs, prepared/submitted and filed
5 BLAs prepared/submitted filed and or approved
3 PMA; 17 510K’s; 2 IDEs; 3 OTC, 2 ANDAs, 2 CTx, 2 MAAs prepared and or submitted and approved
Multiple therapeutic areas track-record, i.e., cardiovascular, central nervous system, dermatology, hepatology, metabolism/endocrine, oncology, thrombosis, nuclear imaging, anti-bioterrorism, ocular, vaccines, infectious disease and various orthopedic medical devices
Successful orchestration of multiple manufacturing sites (3 International) for drug substance/drug product managed through product launch and commercial manufacturing
International product investigation and recall (CAPA) management
Speaker and regulatory trainer - Drug Information Association (DIA -eCTD)
~$20 Billion Peak Annual Sales for Products Developed/Approved
Acquisition of priority review, fast track, accelerated approval, orphan drug, user fee waivers, etc.
Successful manufacturing of “historical pharmaceutical development products” for current submissions of genetically targeted clinical indications with one historical batch record for registration/validation batches
Reorganization of a major academic center including staffing, grants and funding systems, and overall administrative functions according to NIH and FDA quality standards
Interim VP of Project Management, Regulatory and Quality Assurance for the successful management of a pre-clinical rhesus monkey GLP study for an international (China) anti-bioterrorism project-successfully initiating preclinical monkey supportive care studies including hands on training and quality systems development and translation to support significant BARDA and DOD contracts
Development of GMP systems for supplement and herbal manufacturers to support changes in FDA guidelines for successful FDA audits
Reversal of FDA clinical holds
Published scientific author in professional journals
Colorado BioScience/Fitzsimons Redevelopment Project Preferred Provider

Bridging Science to Health, LLC

A Full Service Bio-Pharmaceutical Consulting Enterprise

Achievements