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Expert has over 20 years of broad-based experience with pharmaceutical product development. His work in this area has ranged from early phase 1 drug characterization to phase 4 market product launch and validation. He has significant experience in bringing products to market on a worldwide basis.

Expert has significant experience organizing, developing, and submitting process validation protocols and final reports. The reports were prepared to summarize and detail acceptance criteria and the complaince with FDA requirements. Based on his efforts, he has helped successfully launch four new products at two plant sites. PRE-APPROVAL INSPECTION. He was involved in multiple FDA pre-approval inspections at three sites in the US and Puerto Rico. His team developed standard operating procedures, reports, spreadsheets, and all summary documents for successful pre-approval inspections.

Expert has had significant experience in preparing technical dossiers and CMC implementation for registration and filing purposes for worldwide registration. He has developed protocols and methods of evaluating cleaning procedures for adequately assuring compliance with the most current FDA standards. He has prepared satisfactory cleaning procedures for removing drug residues in accordance with FDA and CGMP requirements. He has audited facilities and plants that manufacture the active pharmaceutical ingredient in bulk drug products. He ensures that the substances comply with FDA requirements.

Experienced in designing and evaluating novel oral drug delivery systems, He and his staff have successfully developed and transferred from Europe a once-a-day antihypertensive drug into the US market. He has been also deeply involved in the formulation of other drug agents, including delivery of peptides via the oral route (as opposed to parenteral administration). He was involved with European companies in selecting and evaluating oral delivery of Calcitonin. He has been deeply involved with the design and scale-up of novel drug delivery systems for parenteral administration. One application involved the surfactant solubilization for lipid soluble agents and nanoparticle systems for intravenous use. The evaluation of manufacturing and sterilization processes were critical elements in this work.

Knowledgeable of pharmaceutical development on a global scale, he is involved in the successful development of a worldwide registration plan for fast-track development and market launch. Expert has been heavily involved in the development and introduction into the European market of a nasal spray delivery system for Calcitonin. He was also very active with multi-dose and unit-dose nasal delivery formulations and packaging systems. Quality control procedures were developed for spray content and spray patterns in accordance with FDA expectations. A significant portion of his career has been involved with international efforts to transfer dosage forms from research and development into plant sites. He has transferred analytical and pharmaceutical drugs from USA to Europe and vice versa. He has also worked in Puerto Rico and various European countries on projects related to scale-up and introduction of programs into production phases. The application of good manufacturing procedures and state-of-art technologies was utilized. He has evaluated polymorphs for effects on drug solubility, bioavailability, and product stability.