Clinical & Regulatory Strategies
OUR SERVICES
 
Product strategy and planning

We can assist you with product definition and placement for both new products about to undergo development as well as currently marketed products seeking new growth through expanded indications.
Product development

We can partner with you for all phases of product development by identifying and evaluating appropriate investigational sites for clinical studies; interacting with regulatory authorities in Europe, Japan, and North America; and performing Quality Assurance audits.
Medical and Regulatory due diligence for company or product acquisition

We can facilitate your program to identify companies or development-stage products that are acquisition targets.

Employee training

We can assure your employees' continued competence by providing training in Good Clinical Practices.

Management Locum Tenens

We can provide hands-on assistance at your site for extended periods over the duration of a project. Think of us as members of your team. Our extensive experience in working in team-based organizations will allow us to blend easily into your organization.

Medical writing

We can perform some or all of your medical writing tasks, such as drafting scientific manuscripts, clinical protocols and study reports, and standard operating procedures.

 
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