Regulatory Affairs

Services and Solutions

Regulatory Expertise

Providing comprehensive regulatory expertise services to support your organization's product development and regulatory needs. The goal is to ensure that your products meet regulatory standards for clinical trials and reach the market efficiently. Here are some of the key services offered:

Contribute regulatory expertise to organizations with products in development

Ensure that all regulatory requirements are met, reducing the risk of delays and non-compliance.

Drive the tactical “hands-on” implementation of regulatory strategy

Taking a hands-on approach to implementing your regulatory strategy. This includes preparing and submitting regulatory documents, liaising with regulatory agencies, and providing support to navigate complex regulatory processes.

Provide strategic regulatory feedback

Offer valuable strategic feedback to help shape your regulatory approach and identify potential challenges and opportunities early on to help make informed decisions that align with business goals and regulatory requirements.

Services

Applications

BLA - US Biologics license application

CTA - Global clinical trial application

CTR - EU clinical trial application

IND - US investigational new drug

MAA - EU Marketing authorisation

NDA - US 505(b)(1) and 505(b)(2) approval pathways

Products

Biologics

Combination drug/device

New pharmaceuticals

Orphan

Diseases

Autoimmune

Cardiovascular

Endocrine

Hepatology

Infectious disease

Neurology

Oncology

Ophthalmology

Rare disease

Respiratory

Treatment/pain

Regions & Countries

Asia Pacific

Canada

Europe

Latin America

United States

Regulatory Support

Briefing documents

Expanded access

Expedited programs

Initial INDs and maintenance

Marketing application support

Orphan designation

Pediatric programs

Regulatory reviews for documents

Additional Regulatory Support

Application transfers

Due diligence

Gap analysis

Mentoring and training

Regulatory Intelligence

Jill Iacopi

Jill Iacopi is the President of Moonbay Regulatory and boasts over 20 years of experience in the pharmaceutical and biotechnology industry. Her career began at Oculex, where she served as a quality control chemist. Her journey soon led her to Pharmacyclics, Inc., where she joined the regulatory affairs department, gaining valuable expertise in the field.


Following her time at Pharmacyclics, Jill transitioned to an independent regulatory affairs consultant role. Her entrepreneurial spirit culminated in the founding of Moonbay Technology in 2004. At Moonbay Technology, Jill developed an innovative web-based document management and electronic publishing system designed to streamline the management of regulatory documents and electronic submissions.


In 2016, Moonbay Technology evolved into Moonbay Regulatory, shifting its focus to the tactical implementation of regulatory strategy. Throughout her career, Jill has collaborated with over thirty-three organizations.


Jill's academic background includes a Bachelor of Arts in Psychology from the University of Washington, which has contributed to her holistic approach to regulatory affairs and strategic implementation.


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