Regulatory Affairs

• Regulatory input for overall strategies in clinical planning, and CMC activities
• Document review for regulatory submissions
• Product labeling, advertising and promotional materials reviews for drugs and cosmetics
• Development of regulatory standard operating procedures
• Strategic team leadership for IND/ NDA planning
• Assistance with FDA registration, drug listings and Board of Pharmacy licensing
• Assessment of product acquisition candidates and follow-up transitional activities related to the purchase or sale of marketed product(s)
• Due diligence activities for products in all phases of development

Business Development

• Identification of opportunities for in-licensing from select therapeutic areas
• Identification of partners for out-licensing
• Identification and assessment of drug delivery systems
• Negotiation of transactions
• Due diligence for licensing opportunities
• Management of alliances
• Development of business and product/technology descriptions for investors

Technology/Marketing

• Market analysis and competitive assessments
• Technology and product assessments
• Development of corporate and partnering presentations
• Development of collateral materials

Quality Systems Design and Evaluation

• Development of SOPs and implementation of quality systems for drug products
• Identification of corporate needs for QA/QC input to programs

Audits / GMPs

• GMP audits (Intermediates; APIs; Finished Drug Products)
• Vendor qualification activities
• Preparation for pre-approval inspections
• Internal training per cGMPs 

Clinical / Medical

• Medical and technical writing
• Clinical protocol and case report form design and development
• Participation in the strategic development and execution of comprehensive drug development programs
• Creation of appropriate standard operating procedures