Professional  Pharmaceutical  Consultants

CMC Strategy and Writing

• Provide strategies for development, as well as for CMC changes to approved products
  
• Write CMC sections for submissions, including INDs, IMPDs, annual reports and eCTDs for NDA (and MAA) approval
  
• Conduct CMC gap analysis on development projects
  
• Serve as liaison between client and manufacturing/research organization
  
• Author documents including; stability and feasibility protocols, development reports
  

 Technical Writing

• Medical and technical writing (abstracts, publications, presentations)
  
• ​Writing fast track and orphan drug submissions
  

Due Diligence

• Activities including technical, business, regulatory (including GMP audits), CMC and clinical assessments of products and technologies
  
• Follow-up transitional activities related to the purchase or sale of marketed products
  

Regulatory Strategy and Submissions

• Strategic team leadership for drug and device submission planning​
• Document review and/or gap analysis for regulatory submissions
  
• Expertise in drug delivery systems and combination products
  
• Creation of regulatory SOPs
  

​Advertising and Promotional Reviews  >

• Requirements for drugs (Rx/OTC), biologics, devices and cosmetics
  
• Promotional strategy assessments and product launch support
  
• Membership on cross-functional promotional review teams
  

Services

Quality Systems and Audits

• Conduct cGMP audits
  
• Perform gap analysis of current GMP systems
  
• Serve as interface between client and suppliers
  
• Provide batch review and product release
  
• Advise on change control issues and failure investigations
  
• Monitor stability programs
  
• Review validation programs
  
• Set up quality systems and SOP creation