Regulatory Affairs Consulting

Hubbell Consulting advises our clients to ensure that they fulfill regulatory, scientific and clinical requirements and comply with the laws and regulations required by worldwide regulatory agencies. Our consultants work directly with regulatory agencies on our clients' behalf. Hubbell Consulting has experience in the following areas:

• Regulatory strategy development

• IND and IDE submissions and maintenance (including Annual Reports)

• GCP, GLP and GMP audit

• Develop strategy and run Pre-IND, Pre-NDA meeting

• Pre-IND, Pre-NDA briefing packages

• Presentations to the FDA

• Negotiations with FDA

• Responses to FDA inspections (483s) and other FDA correspondence

• 505(b)(2) strategy and NDA submission preparation

• eCTD preparation: Module 2 (2.2, 2.4, 2.5, 2.6, 2.7) and Module 5 (ISS, ISE, 505 (b)(2) summaries)

• Due diligence for technology licensing

• Toxicology package development