- Services -

CONSULTANCY SERVICES

Salzman Group’s integrated approach is to evaluate the scientific, medical, regulatory, and commercial aspects of your product development opportunity to maximize the value creation of your project at any stage of development. With our integrated approach, the team at Salzman Group manages every aspect of your program, from hit selection, drug design, formulation, and testing of the drug product, to conducting nonclinical and clinical studies. Based on over two decades of internal drug development (track record) the Salzman Group offers a boutique service for moving your drug development project towards clinical proof of concept, whether in regulatory, managerial, strategic, or business aspects. The combination with our Contract Research Services provides the benefit of an efficient one-stop-shop solution, that includes all aspects of your development project.

We address these essential questions with our clients,
in order to maximize their  success: 

  • What is your goal? (milestones, raising grant or investor funding, satisfying collaborators)
  • How should you benchmark? (efficacy, tolerability, costs of goods, administration route & schedule)  
  • What are ways to guarantee success? (appropriate exposure in the target organ)
Drug Development Plan / Program Management Regulatory Affairs Intellectual Property Diligence, Development Strategy Strategic Business Consulting

Drug Development Plan / Program Management

We offer a turn-key package of drug development, from discovery through Phase II proof-of-concept trials. We begin this process at a kick-off meeting, preferably face-to-face, that establishes your target product profile and assembles a development budget, timeline, and exhaustively detailed project plan. This meeting is the most critical aspect of what the Salzman Group offers because it integrates basic science, technology assessment, chemistry, safety, ADME/PK, clinical trial issues, regulatory affairs, clinical medicine, intellectual property, and marketing. 
 


Regulatory Affairs

After transferring fifteen molecules into clinical testing, we are a strong partner for Regulatory Intelligence & Strategy, providing guidance and management from Gap Analysis to FDA and EMEA meetings. Our team can prepare all required components of regulatory submissions, including clinical synopses, pre-IND meeting dossiers, and full eCTD IND/CTA/CTX packages for the US FDA, EMEA, TGA (Australia), and MOH (Israel). 


Intellectual Property Diligence, Development Strategy

We are dedicated to innovative drug development and have gained vast expertise on the generation of value for a discovery project, bringing your company to an inflection point that will attract funding. We offer IP diligence to identify freedom-to-operate for novel active pharmaceutical ingredients and manufacturing processes, prodrugs, and metabolites.

 


Strategic Business Consulting

No innovative drug development program can survive without a sound financial basis. We provide strategic business consulting to guide and manage equity capital raises, strategic partnerships, and fundraising via non-dilutional grants (track record). We can package your technology in such a way that potential investors will find the answers they are seeking.

 


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