Scope of Services

qd consulting, LLC

Clinical Development


Advise on clinical development strategies, target populations, study designs, endpoints etc, to meet indication and regulatory objectives


 Advise/develop novel study design options, especially for early proof-of-concept

 

Construct clinical development strategies and detailed clinical development plans (eg, study populations, study designs and endpoints, number of studies) to achieve regulatory objectives


Critical review and content assistance in FDA/EMEA submission documents including integrated summaries, clinical overview, SPC/package insert, study reports, protocols, investigator’s brochures, etc


Advise on, review and prepare clinical briefing documents for FDA meetings

 

Regulatory Affairs


Develop regulatory objectives and strategies for initiating human research (INDs) and registering products (NDAs).  Identify and advise on strategies for addressing regulatory risks/issues


Prepare regulatory documents: eg, integrated dossier summaries, justifications for regulatory strategy, FDA meeting requests and background documents, orphan drug applications, requests for fast track status


Plan, compile, and submit original INDs, annual IND updates, and IND amendments


Plan, manage and facilitate meetings with FDA


Provide relevant information and guidance regarding precedents, requirements, activities, trends, and changes in the drug regulatory environment.

 

Due Diligence and In-Licensing Assessments


Assess early development opportunities


Perform clinical and regulatory due diligence of potential licensing opportunities


Compile clinical and regulatory due diligence reports

 

Scientific Writing


Common Core Technical Document clinical modules 2 and 5


Clinical Trial Study reports