Traxeus Pharma Services Competitors

CMC Pharma is a leading contract development and manufacturing organization (CDMO) committed to helping pharmaceutical and biotech companies develop new and better drug products. We provide exceptional drug product R&D services including formulation and analytical development, stability evaluations, drug delivery system design, and prototype preparation services. We are experts in innovative and complex delivery systems including polymeric controlled release, in situ forming gels, suspensions, and more. We focus on pharmaceutical projects that require wide ranging consulting services, pre-formulation characterization, formulation development, analytical chemistry, stability evaluation, novel drug delivery systems, process development and drug product characterization studies. Our capabilities and services are appropriate for programs from early to late-stage development through FDA approval and commercial launch. CMC utilizes a consortium of seasoned PhD chemists and engineers that provide Chemistry, Manufacturing, and Controls expertise to the pharmaceutical industry. CMC’s President, Mike Radomsky, has a PhD in chemical engineering from The Johns Hopkins University and 25 years of experience in the pharmaceutical industry. Radomsky is the inventor and author of dozens of patents and scientific publications focused on the formulation and manufacture of drug products. Much like Radomsky, our employees have been everywhere – From Big pharma to emerging start-ups. Our pharmaceutical scientists typically each have more than two decades of experience in the pharmaceutical or biotech industry. This experience in pharmaceutical development and our modern R&D laboratory are ideally suited to meet all of your drug product development needs.

Velesco applies nimblocity to your early stage drug development projects, with our proven formulation of expertise, flexibility, dedication, and velocity to clinic. Expertise and experience Velesco is a CMC contract research organization, founded and staffed by pharmaceutical scientists from Pfizer's former Michigan R&D campus. Our team has experience with more than 100 drug development programs. Flexibility Our nimble processes and focused expertise enables us to overcome even the most challenging obstacles. Our team is responsive, accommodating, and eager to help you reach the full potential of your compound, quickly and efficiently. Personalized Partnerships We treat your project like it's our own and share everything from insightful observations to solutions for problematic analytic methods, to assistance with the FDA registration process. All our services are royalty-free. Velocity to clinic We're committed to getting your compound to the clinic on time. Our size, capacity, and expertise allow us to accommodate changes swiftly while maintaining control and quality. As experts in pharmaceutical analytical chemistry, drug formulation development, and cGMP clinical supply manufacture, Velesco scientists have a proven track record of moving compounds through the critical drug development process with nimblocity and unrivaled success.

John C. Amedio, PhD, Principal at Amedio CMC Consulting, assists emerging and established pharmaceutical and life science companies with the technical and regulatory CMC development of small molecules and peptides from the bench to the market. John has a proven track record of delivering results on time. He provides leadership and guidance in drug development, regulatory affairs and quality programs. John has 25 years of experience in major and start-up pharmaceutical companies with expertise that spans organic chemistry, process research and development, analytical method development, formulation development, cGMP manufacture for drug substance and drug product (parenteral, lyophilized, ophthalmic, solid dosage forms). He has extensive knowledge in primary/packaging, labeling and supply chain/distribution activities and has performed several technology transfers to and from CMOs. John has delivered numerous profitable and patented manufacturing processes for both drug substance and drug product. He has authored and reviewed CMC sections for multiple regulatory filings (INDs, Amendments, Annual Updates, Briefing Books and an NDA; IMPD documentation to EMA and Canadian authorities), participated in face-to-face FDA meetings (pre-IND, end-of-phase 1, end-of-phase 2 and pre-NDA), performed budget planning and forecasts, established hiring plans, and contributed to the overall strategic planning. He is a lead author or co-author of several peer-reviewed articles, publications and patents and has given many invited presentations. John held positions as Vice President of Manufacturing and Process Development at Seaside Therapeutics, VP of Manufacturing and Process Development at ZIOPHARM Oncology, Executive Director, Chemical and Analytical Development, EPIX Pharmaceuticals and Unit Head, Chemical Development, at Sandoz Research Institute (currently Novartis). © 2013 Amedio CMC Consulting LLC | Website: gatestudio.com