Experienced Pharmaceutical Scientists Ready to Turn Your Product Development Ideas and Requirements Into A Reality

Trust our dedicated team to complete even the most complex testing project on-time and within budget. Our product development services include the following:

  • Pre-Formulation Evaluation
  • Analysis of Drug Product
  • Formulation Development
  • Product Remediation
  • Formulation Preparation
  • Formulation Screening and Identification
  • Stability and Compatibility Studies
  • Formulation and process trouble shooting
  • Preparation of IND and NDA chemistry sections for FDA
  • Identification and management of pharmaceutical supply chains

Free Consultation

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Experienced Formulation Chemists Ready to Meet Your Product Development Needs

The custom formulation and analytical development services at CMC Pharmaceuticals help product developers, manufacturers and entrepreneurs turn innovative ideas into approved products or remediate existing products to meet current FDA regulations. Our pharmaceutical chemists can meet your product development needs upon understanding the characteristics and the requirements of your pharmaceutical product. We take the time to listen to your requirements and any deficiencies the FDA may have noted and evaluate and recommend the appropriate course of action. Our experienced and skilled team of chemists will go to work on an agreed upon product development or remediation plan.

We will work with you to refine your products to meet your and the FDA’s exact specifications and requirements. We are available throughout the development and experimental process to bring your product to commercial reality.

imgWhy Choose CMC Pharmaceuticals:

  • Free Initial, No-Obligation Consultation with a Pharmaceutical Chemist
  • Modern R&D Lab with Wide Range of State-of-Art Instrumentation and equipment
  • Extensive Experience Solving and Testing pharmaceutical Development Projects
  • Responsive Staff who are Flexible to Meet Your Needs
  • Wealth of Knowledge & Technical Expertise
  • Project Customization
  • Detailed and Accurate Results

Meet Our Team

Mike Radomsky, PhD

Dr. Radomsky received his PhD in chemical engineering in 1991 from The Johns Hopkins University and has a nearly 25 year uninterrupted career in the pharmaceutical industry.  He has served in a number of technical roles at both big pharma and small startup pharmaceutical and biotech companies.  He has held technical positions at Syntex/Roche, Orquest, Epicyte, Arc Engineering, Boehringer-Ingelheim and most recently had a role as a founder and Vice President of Technical Operations at Oncogenerix/DARA Biosciences.  He provides expertise in the chemistry, manufacturing, and controls for a wide variety of pharmaceutical products and has led product approvals and manufacturing efforts at contract manufacturing organizations (CMOs) around the world.  His expertise has led to demonstrated success in advancing generic and innovator product pipelines to product approval and launch, utilizing CMOs and CROs for virtual development and manufacturing, and leading large and small groups of cross functional scientists.   Dr. Radomsky has established a broad based knowledge of the FDA regulations of pharmaceutical products and a strong history in the development of intellectual property including a number of formulation and drug delivery patents.  He has been consulting on and off in the industry since 2001.

DONALD DUWE,

Donald Duwe received his BS in Analytical Chemistry in 1994 from Kent State University and has over 20 years experience in the pharmaceutical industry. He has held technical and senior management level positions in large regulated manufacturing facilities. He provides expertise in analytical testing, stability management, remediation, method development and transfer of drug products. Donald has a broad based knowledge with FDA regulations and is experienced with remediation

CMC Pharma Consortium

CMC Pharma is also engaged in a pharmaceutical chemistry consortium to provide additional technical experience and expertise if necessary. The consortium consists of PhD chemists and engineers, each with over 20 years experience in research, development, and manufacturing of pharmaceutical products.