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
Clinical Strategy and Writing
  • Medical and technical writing (abstracts, publications, presentations)
  • Clinical protocol and case report development
  • Participation in drug development strategies
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
  • Planning and writing fast track and orphan drug submissions
  • Document review and/or gap analysis for regulatory submissions
  • Expertise in drug delivery systems and combination products
  • Creation of regulatory SOPs

Services


LLC


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



Business Development
  • Identification of opportunities for in-licensing
  • Identification of partners for out-licensing
  • Negotiations and closing of transactions
  • Product / technology descriptions for investors
  • Development of corporate and partnering presentations


Technology Assessment
  • Assessment of products, technologies and drug delivery systems
  • Market analysis and competitive assessments
Advertising and Promotional Reviews  >
  • OPDP requirements for drugs, biologics and devices
  • Promotional strategy assessments and product launch support
  • Membership on cross-functional promotional review teams