HMD Pharmaceutical Consulting LLC

Projects

  • Due diligence and clinical development programs for several new Rx-to-OTC opportunities in the upper respiratory category, and women’s health

  • Due diligence reviews for medical devices, small molecules and biologics in both upper and lower respiratory categories

  • Development of clinical protocol in the Pediatric Cough/Cold Category, sought out appropriate CRO’s to conduct a complex study, and obtained bids for a potential Sponsor

  • Participated in advisory boards in the immunology and respiratory categories and mock FDA presentations

  • Advised several OTC manufacturers on FDA regulatory strategy issues, and clinical project design

  • Advised venture capital and other financial institutions on advisability of investment in early and late stage projects

  • Developed clinical programs for U.S regulatory approval as drugs and new claims for complementary medicines

  • Developed a novel KOL and advisory board program

  • Development of strategies for advertising review at NAD

  • Development plans for herbal actives to be approved as drugs in U.S.

  • Development of a new product for an oncology indication

  • A novel immunology product for Europe

  • Advertising and promotion review; development of challenges and responses

  • Sales force training

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