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 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 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.
Regulatory Affairs
Regulatory Affairs services include a wide range of regulatory affairs guidance and expertise to facilitate effective interactions with regulatory authorities in order to accelerate drug development. Here are some of the services Pacific BioDevelopment offers in this arena:
- Provide innovative drug/biologic development strategies to meet corporate goals.
- Provide strategic guidance, personnel training, and expert review of regulatory submissions.
- Provide interim management and oversight of your Regulatory Affairs department.
- Accompany you to meetings with regulatory authorities to represent you or to provide impartial outcome analyses.
- Perform due diligence assessments for in-licensing opportunities.
- Serve as a US Agent for foreign companies
