Get Letter Of Intent (loi) Guidelines

This guide provides a clear and user-friendly approach to filling out the Letter Of Intent (LOI) Guidelines. It is designed to assist individuals in understanding each section of the form and ensuring that all necessary information is included when applying for a clinical registrant partnership with the University of Pittsburgh School of Medicine.

Follow the steps to successfully complete your LOI

1. Click the ‘Get Form’ button to access the LOI form. This will allow you to open the document and begin entering your information in the appropriate sections.
2. Fill out the primary contact information as required in section I.A. Ensure to include the name, title, company, mailing address, phone number, email address, and website (if applicable).
3. Continue with section I.B by detailing your current capitalization and plans for raising additional capital for research. Describe your corporate structure in a concise manner, adhering to the 200-word limit.
4. In section I.C, elaborate on your partnership plan with the University of Pittsburgh within a 500-word limit. Include specific medical conditions you aim to address and the scientific rationale supporting your choices.
5. Move on to section I.D and outline the experience and expertise of your organization. Address previous FDA Investigational New Drug applications and related clinical trial experiences as outlined.
6. Complete section I.E regarding manufacturing processes. Provide detailed descriptions of your current product offerings and manufacturing standards within the specified word limits.
7. In section I.F, address the legal considerations your organization has set to manage potential Drug Enforcement Agency actions and compliance with federal financial regulations. Limit your response to 300 words.
8. For section I.G, list advisory board members along with applicable CVs or résumés and NIH biosketches. Ensure this information is clearly organized.
9. Consider including optional information in Appendix B to support your application further. This could consist of peer-reviewed literature and other relevant materials within the required guidelines.
10. Review all entered data for accuracy and compliance with format requirements. Once finalized, save your document, convert it to a PDF file, and prepare one hard copy and one electronic version on a USB drive for submission.

Complete your Letter Of Intent (LOI) application online now to seize this partnership opportunity.