Work from our office or on site
Experience with injectable solutions and suspensions and aseptic manufacturing
Data trending, review and CMC writing. Multiple NDA's submitted as eCTD's.
Work from our office or on site
Testimonials
"Over the past 10 months, you (Bob Malone) provided tremendous help and support to our development, especially in QA/QC, a major development project, and to me personally. I really appreciate your efforts and hard work."
- Dr. Bin Wu, President of Phosphorex Inc.
"I had the pleasure to work with Bob both at Sepracor and Agno Pharma. Bob is a terrific CMC manager with a passion for commercial development. He also possesses a strong analytical expertise. I worked with him on few projects and found him inquisitive, analytical, a strategic thinker and intellectually honest. He is methodical and detail oriented. He brings new ideas to the table all the time and follows through with them. Bob is second to none in execution. He is heavily engaged and motivated. Bob collaborates and works well with people. I have found Bob to be an excellent scientist and a very likable person. It has been real fun for me to work alongside Bob."
- Paul Grover, Sr. Director of Business Development, Agno Pharmaceuticals
"Bob is a very knowledgeable and experienced product development and CMC leader. He understands all aspects of commercial development and is especially strong in the areas of process development, test methods, regulatory submissions and quality systems. He is a rare combination of strategic thinker and detail-oriented tactician. I have learned a lot from Bob, value his strong technical and analytical capabilities and appreciate his ability to make the complex simple. He would be an outstanding addition to any program in need of veteran leadership to ensure it stays on course with the most efficient pathway to market."
- Ralph Solarski, President and CEO, Genacept, LLC
"When Meda Pharmaceuticals bought Acton Pharmaceuticals the commercial launch of Aerospan was imminent. I had just met Bob, but I needed to rely on him to support launch due to my promotion to head of U.S. Quality. Bob’s integration into our group was seamless and his experience proved beneficial to my group beyond just his continued oversight of quality for Aerospan and its complex supply chain. He also developed and implemented several cost control projects and supported the tech transfer of four aerosol products to a new site."
- Francisco E.Baez, Sr. Director Quality Assurance and Compliance for Meda Pharmaceuticals