SERVICES

Our expertise includes:​

• Dossier/submission preparation or review and filing (pre-submission packages, INDs//CTAs/IDEs and post-filing submission, BLA/NDA/NDS/MAA/510(k)/PMA filings (US, Canada, EU, Asia)
• Development of regulatory strategy for the product’s life cycle
• Facilitate interaction with regulatory agencies, meetings and conference calls, negotiations during development stages, submissions and submission approval process.
• Provide expert regulatory CMC compliance advice throughout development.
• Work with Sponsors and regulatory authorities through the resolution of complex development issues.
• Act as US Representative for US submissions for non-US clients.
• Assist with due diligence activities for investors/licensees. 

DICON GROUP LLC

We have extensive Clinical Operations expertise in managing clinical programs for a diversity of products which include selection and overseeing of CROs and GMP manufacturers; managing studies from preclinical (animal), through Phases I, II and III; integrated efficacy and safety, document preparation, and filing of  marketing applications (NDA, NDS and MAA) in eCTD format.

• Comprehensive regulatory and scientific drug/device development strategies for international registrations. Facilitate interaction with regulatory agencies.

• Regulatory assistance with quality, safety, and efficacy issues for diverse types of therapeutic products and devices.

• Scientific writing of both clinical (protocols, plans and trial materials) and CMC documents

• Preparation/review of submissions.