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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.

    Labeling and Promotional Materials

    Labeling and Promotional Materials services cover all aspects of label and promotional material development, including negotiations with both DDMAC (drugs) and APPLS (biologics) committees. Here are some of the services Pacific BioDevelopment offers in this arena:

    • Assist with the development and implementation of systems and procedures for investigational and commercial labels/labeling, promotional, and educational materials review and approval.
    • Assist with the establishment, implementation, and reporting procedures for NDC Drug Listing systems.
    • Assist with the development and implementation of launch plans and strategies for advertising, press releases, sales brochures and formulary kits, including vendor selection.
    • Assist with the development and strategies for pre- and post-approval activities, including conventions and press materials, and FDA pre-clearance strategies.
    • Perform training for regulatory, marketing, corporate communications, and field sales and establish promotional review systems.
    • Review website design and content for compliance.
    • Provide interim management and oversight for clients without internal staff.

    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