• Identification and assessment of new topical drug delivery systems for a currently marketed product that provides differentiation and proprietary protection.
• Comprehensive due diligence on dermatology products/technologies being considered for in-licensing.
• Identification and characterization of active components in a bioengineered product.
• Identification of means to differentiate a client’s soon to be launched product vs competitors.
• Preparation of presentations for a client’s scientific advisory boards on new technology opportunities.
• Preparation and review of technical and business documents for investors.
• Identification of products for potential in-licensing by therapeutic area and revenue.
• Development of pre-approval and direct-to-consumer advertising campaigns.
• Provision of regulatory expertise, guidance and technical writing for a supplemental NDA submission in support of a combination product enhancement.
• Provision of regulatory guidance for the technical transfer of drug products (oral and topical) and drug substances.
• Assumed temporary position of regulatory department head during a company’s transition period.
• Regulatory due diligence for multiple product acquisitions including dermatological, anti-infective and inhalation drug products.
• Creation of regulatory and quality functions for several start-up companies, as well as obtaining appropriate regulatory and board of pharmacy licenses.
• Establishment of quality systems and regulatory strategy, as well as the creation of outsourced Call Center (and verification of SOPs) for a new commercial pharmaceutical organization.
• Development of corporate quality manual and quality agreements with suppliers
