Drug Product Development and Consulting

Experts in Pre-formulation, Formulation and Analytical Chemistry to provide all of your Drug Product development needs.

CMC Pharmaceuticals Inc. is a pre-formulation, formulation and drug product consulting and contract lab services organization. Our decades of experience in pharmaceutical development and our modern R&D laboratory are ideally suited to meet all of your drug product development needs. We focus on pharmaceutical projects that require wide ranging consulting services, pre-formulation characterization, formulation development or later-stage Drug Product characterization studies. We have focused on compounds in discovery & early development, sterile injectable products, novel dosage forms, formulations of poorly soluble, potent or unstable compounds, controlled release formulations, and characterization & stability studies required for IND and NDA approval.

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. He is the inventor and author of dozens of patents and scientific publications focused on the formulation and manufacture of drug products. The company leverages our scientists’ extensive background in the formulation, analysis, and manufacturing of pharmaceuticals with an emphasis on those with significant technical and manufacturing challenges.

Our consultants 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. Please do not hesitate to contact us to discuss your Drug Product consulting and lab services needs.

Services

What We Do

Drug Product Lab Services

CMC provides a multitude of high quality lab services made possible by our broad history in the pharmaceutical industry and highlighted with our ability to customize services to your specific needs.

SOLUBILITY

We have evaluated the solubility of active pharmaceutical ingredients in a number of pharmaceutically relevant solvents.

LC/MS

Our LC mass spectrometry detector provides a valuable tool for method development, impurity & degradant identification, and a variety of trouble shooting applications.

STABILITY

Our temperature and humidity controlled stability chambers are used in a variety of long-term, accelerated stability, and forced degradation studies.

HPLC/UPLC

Our liquid chromatography instrumentation provides capabilities to precisely test a large range of substances to determine potency, purity, degradation, composition, etc.

DISSOLUTION

Our USP dissolution apparatus provides capabilities to execute the dissolution of a wide variety of dosage forms by the USP and other compendial requirements.

Drug Product Development

CMC provides Formulation and Drug Product Development Laboratory Services to our clients. Our decades of experience in pharmaceutical development and our modern R&D laboratory are ideally suited to meet all of your drug product development needs.

REGULATORY FILINGS

Authoring & review of CMC regulatory filings is one of our core competencies. We have extensive experience in preparing drug product documents for INDs, NDAs, FDA queries, supplements and amendments, annual reports, site inspection observations, 483’s and warning letters.

PROJECT TEAM SUPPORT

The successful development of a pharmaceutical product requires a well functioning project team. CMC has provided significant expertise and contributed to virtual product development and manufacturing teams. Providing decades of experience in a cost effective manner for a project can significantly reduce overall costs while expediting development.

TECHNICAL BUSINESS SUPPORT

CMC has provided clients with technical support during due diligence for product out- and in-licensing as well as technical support for M&A activities. We have also provided business development support for technologies that require extensive technical interactions.

DRUG PRODUCT INSTRUCTIONS

Dosage preparation instructions are required for INDs, NDAs, non-clinical and clinical protocols, and investigator’s brochures. We have extensive experience in reviewing and preparing these documents.

Drug Product Consulting

CMC provides technical consulting expertise to the pharmaceutical and biotech industry, and our extensive and collective experiences provide us the ability to provide valuable input on a broad range of topics.

PREFORMULATION CHARACTERIZATION

These studies can be customized to include excipient compatibility, solid form evaluation, solubility measurements in pharmaceutically acceptable solvents, pKa determination, forced degradation studies, pH degradation rate profile, evaluation of adverse conditions (water/humidity, temperature excursions, oxygen, light, freeze/thaw, etc.) and other studies as needed to evaluate and active pharmaceutical ingredient (API) for pre-clinical or clinical studies.

SMALL MOLECULE ANALYTICAL CHARACTERIZATION

CMC’s is well equipped to analyze drug products by a number of advanced techniques that include HPLC, UPLC, UV/V is spectrophotometer, visual analysis, and other analytical techniques. Our Cleveland Health-Tech Corridor location provides financial incentives to purchase equipment and access to a wealth of advanced lab services at the area’s universities and hospitals.

FORMULATION DEVELOPMENT

CMC can execute studies and evaluate the physicochemical properties of an API and recommend an appropriate dosage form for preclinical and clinical studies. Prototype formulations are prepared and evaluated under stressed, ICH, and custom conditions. We have extensive expertise in evaluating the stability and compatibility of drug products at various storage and in-use conditions to support stability during clinical trials and commercialization and in support of IND and NDA filings.

FORMULATION PREPARATION: SOLID ORAL AND STERILE/NONSTERILE LIQUIDS

CMC can prepare a number of traditional and complex dosage forms for in vitro and in vivo exploratory, proof-of-concept, and toxicology studies. We can provide the appropriate analysis and documentation to support each stage of development.

“The opportunity for CMC to provide consulting and laboratory development services to our clients is truly exciting. We provide high quality deliverables to our clientele by leveraging our technical expertise in the pharmaceutical industry” stated Mike Radomsky, CMC’s President. “Having the ability to execute and provide a wide range of product development services quickly and cost-effectively provides significant competitive advantages to our clients.”

Dr. Radomsky