Company Profile

Bert Spilker

Contact Us:

8004 Overhill Road
Bethesda, Maryland

Phone: 301-718-5150
Fax: 301-657-1403
E-mail: bas@bertspilker.com
Alt E-mail: bertspilker0@gmail.com

Brochures: (Acrobat)

  • Bert Spilker & Associates
  • "Enhancing Your Meetings with FDA"
  • . Key Services

    Note: for information regarding our fees please contact us using the contact information on the left hand side of this page.

  • FDA Meetings
  • Regulatory Affairs
  • Drug Development, Clinical Trials
  • Scientific Management for Early Stage Companies
  • Drug Policy Issues
  • Practical Services
  • Legal Support Services
  • Training/Courses
  • FDA Meetings

  • "Enhancing Your Meetings with FDA" (Adobe Acrobat)

    Regulatory Affairs

    • Advise on clinical or regulatory strategies, emphasizing creative "out-of-the-box" approaches
    • Evaluate and critique regulatory submissions or communications
    • Assist in the preparation for FDA meetings
    • Advise on political issues, health policies and regulatory trends
    • Prepare INDs, FDA Orphan Drug Grants and Requests for Designation
    • Attend meetings to "challenge" strategies and plans
    • Attend rehearsals for regulatory meetings
    • Speak on current topics of interest (See "Expanded Services")

    Drug Development--Clinical Trials--Licensing

    • Strategize on drug development approaches to achieve early approval
    • Create or evaluate strategies for optimizing clinical protocol contents, design, site selection or other clinical trial elements
    • Prepare or evaluate reports
    • Assist in the development of a licensing strategy or conduct due diligence
    • Review a project's status and provide suggestions to shorten development and improve efficiency
    • Speak on current topics (See "Expanded Services")
    • Coach the project team on key issues, options and recommended approaches

    Scientific Management for Early Stage Corporations

    • Counsel on scientific management issues
    • Assess organizational structure and strategies
    • Review business plans and resource strategies
    • Conduct legislative analyses
    • Diagnose problems

    Drug Policy Issues

    • Conduct research on topics of importance to organizations

    Practical Services

    • Mentor senior staff and serve as a sounding board
    • Help solve regulatory or development problems
    • Provide world class experts in most development areas
    • Facilitate, moderate or attend meetings at your organization
    • Act as a mediator for disputes between organizations
    • Attend external meetings on your behalf, when senior staff are too busy, and you want to know what is said
    • Speak on behalf of your organization when you wish to promote a message through a speaking tour
    • Write or edit white papers
    • Act as a "troubleshooter" and suggest options or shortcuts

    Legal Support Services

    • Develop strategies for presenting a legal case
    • Analyze medical documents
    • Serve as an expert witness

    Bert Spilker & Associates provides these services primarily through meeting with key organization staff as a group, or one-on-one, to work through the issues, join a team, or provide a report.

    Consider having Dr. Spilker and/or his team help you move existing projects forward with fresh insight or take advantage of this outstanding resource to successfully initiate a new project.


    Dr. Spilker has taught over 40 one to three day courses in 11 countries. These courses have been sponsored by professional associations, trade associations (e.g., PMA of Canada), CROs, and pharmaceutical companies. These countries are:

    • Belgium
    • Canada
    • Denmark
    • France
    • Israel
    • The Netherlands
    • Spain
    • Sweden
    • Switzerland
    • United Kingdom
    • United States

    In-House Custom Courses

    In-House Courses are custom designed one-day programs for 10 to 100 participants. Over 75 modules are available to create the custom course that is right for your organization. U-shaped seating arrangements are used whenever possible to facilitate interaction.

    Fees are based on the amount of preparation, travel and number of attendees scheduled.

    Call or e-mail for additional information.

    Courses feature interaction with the participants, group learning and a sharing of experiences through discussions.

    Industry Courses (To be Scheduled)

  • Copyright © 2002-2013 Bert Spilker & Associates, LLC. All rights reserved.