Regulatory Support for Drug Development
Key Objectives
- Contribute regulatory expertise to organizations with products in development
- Drive the tactical “hands-on” implementation of regulatory strategy
- Provide strategic regulatory feedback
Expertise
Regulatory Support for Marketing Applications
NDA · BLA · MAA
M1-M5 organization, compilation, and review
M2 QC against M3-M5
Applications
IND · CTA · BLA · NDA [505(b)(1) & 505(b)(2) approval pathways] · MAA
Products
new pharmaceuticals · biologics · orphan · combination drug/device
Disease Areas
autoimmune · cardiovascular · endocrine · infectious disease · neurology · oncology · ophthalmology · rare disease · respiratory · treatment/pain
Regions/Countries
United States · European Union · Canada · Asia Pacific · Latin America
Regulatory Lead & Support for Clinical Stage Products
Initial IND for FDA and CTA for ex-US competent authorities
Briefing documents
Agency meeting planning, preparation, and conduct
IND and CTA maintenance
Expedited programs
Pediatric study and investigational plans
Orphan drug applications and annual reports
Expanded Access Programs
Regulatory document reviews
Other Regulatory Activities
Due diligence
Gap analysis
Application transfer activities
Regulatory Intelligence including review of SBAs
Regulatory mentoring and training
Electronic Documents & Submissions
Establish outline of documents for electronic submissions
Establish QC checklists for major submissions
Jill Iacopi is President of Moonbay Regulatory and has been involved the pharmaceutical and biotechnology industry for over 20 years. Jill started her career at Oculex as a quality control chemist and later joined Pharmacyclics, Inc. in the regulatory affairs department. After Pharmacyclics, Jill became an independent regulatory affairs consultant before founding Moonbay Technology in 2004. At Moonbay Technology, Jill developed a web-based document management and electronic publishing system for the purpose of managing regulatory documents and publishing electronic submissions. Moonbay Technology changed to Moonbay Regulatory in 2016 and focused on the tactical implementation of regulatory strategy. Jill has worked with over twenty-six organizations with clinical stage products. Jill holds a bachelor of arts in psychology from the University of Washington.
