Regulatory Affairs
Editing and Electronic Submissions
Editing and Electronic Submissions services include all aspects of coordinating and preparing regulatory documentation. Here are some of the services Pacific BioDevelopment offers in this arena:
- Develop strategies for producing paper and electronic Investigational New Drug (IND) and drug product market applications consistent with current U.S. and the International Committee on Harmonization (ICH) guidelines
- Edit documents for optimum presentation to facilitate agency review, and to provide consistency with supporting documents
- Provide training in the development and use of templates for paper and electronic drug marketing submissions
- Provide interim management and oversight for clients without internal staff
- Provide a secure environment for remote document sharing and collaboration using SFTP
- Pacific BioDevelopment is partnered with Omnicia, Inc. for Electronic Publishing solutions and is 21 CFR Part 11 Compliant.
