BLAs, NDAs, and PMAs require strategic communication.
Our BLA / NDA / PMA messaging and prototyping consulting applies principles of strategic communication to preparation, resulting in BLA / NDA / PMA messages that are strong, consistent, and clear; issues and resolutions that are fully explored and explained; support that is identified and effectively placed.
We help you achieve precision in every component and aspect of your BLA / NDA / PMA so that its collective messages – regulatory, clinical, and post-marketing – can be integrated into one seamless and strongly supported document. By matching our communication, rhetorical, and regulatory expertise to your needs, we assist you in building a persuasive scientific argument for your product and indication. We guide you in the shaping and telling of the scientific story.
And if you are scheduled to appear before an Advisory Committee, this productive and consistent attention to messaging will enable you to expedite your preparation for the meeting.
Using External Experts to Your Advantage
Our expertise in facilitating multiple perspectives and inputs aids in making your external experts more effective for you and helps your internal team to implement their advice. Success is not about accumulating advice – it is about actuating the advice into winning arguments and persuasive communication
By utilizing ECG's BLA / NDA / PMA messaging and prototyping consulting services, the resulting messages are clear, consistent, and compelling. This will instill confidence that the applicant has provided reasonable assurance of safety and effectiveness.
Please contact us via email or at +1-201-894-8200 to discuss your needs or to get further information on our BLA / NDA / PMA messaging and prototyping services.