CMC Pharmaceuticals, Inc.
CMC Pharmaceuticals, Inc. provides integrated services supporting drug development for small molecule therapeutics and medical countermeasures. The company offers comprehensive solutions for formulation and process development, analytical method validation, stability and compatibility testing, manufacturing oversight, and regulatory support across all phases—including specialized expertise in handling highly potent compounds and government MCM (Medical Countermeasure) programs. In-house laboratories and robust regulatory systems ensure submission-ready, compliant data, addressing the safety and operational requirements of both commercial and defense sectors.
Industries
Nr. of Employees
small (1-50)
CMC Pharmaceuticals, Inc.
30625 Solon Rd Unit G Solon, OH 44139
Services
End-to-end services for pre-formulation, formulation optimization, prototype production, and process development for traditional, complex, and highly potent drug products.
Development, optimization, validation, and execution of analytical methods; routine testing, impurity profiling, and GMP lot release testing including trace analysis for HPAPIs.
Design and execution of ICH-compliant stability programs, shelf-life determination, accelerated and real-time studies, and compatibility with containers and materials under containment for potency or hazardous compounds.
Technical, regulatory, and quality oversight of contract manufacturing operations; includes CMO evaluation, qualification, containment verification, and ongoing monitoring, particularly for HPAPIs.
Preparation and review of regulatory modules, gap assessment, data integration, and response strategy for regulatory submissions, including requirements unique to highly potent compounds.
Planning, cross-validation, verification, and documentation for transfer of analytical methods across labs or manufacturing sites, with a focus on regulatory compliance and data integrity.
End-to-end services for pre-formulation, formulation optimization, prototype production, and process development for traditional, complex, and highly potent drug products.
Development, optimization, validation, and execution of analytical methods; routine testing, impurity profiling, and GMP lot release testing including trace analysis for HPAPIs.
Design and execution of ICH-compliant stability programs, shelf-life determination, accelerated and real-time studies, and compatibility with containers and materials under containment for potency or hazardous compounds.
Technical, regulatory, and quality oversight of contract manufacturing operations; includes CMO evaluation, qualification, containment verification, and ongoing monitoring, particularly for HPAPIs.
Preparation and review of regulatory modules, gap assessment, data integration, and response strategy for regulatory submissions, including requirements unique to highly potent compounds.
Planning, cross-validation, verification, and documentation for transfer of analytical methods across labs or manufacturing sites, with a focus on regulatory compliance and data integrity.
Expertise Areas
- Drug formulation development
- Highly potent compound development
- Medical countermeasure development
- Analytical method development
Key Technologies
- High-performance liquid chromatography (HPLC)
- Ultra-high performance liquid chromatography (UHPLC)
- Liquid chromatography-mass spectrometry (LC-MS)
- Dissolution testing
Key People
News & Updates
Celebrated five years since founding in 2014, marking the growth from a consulting firm to a company with R&D and cGMP laboratories and increased staff.
First unannounced FDA cGMP inspection resulted in no objectionable conditions (no Form 483 issued), affirming compliance for cGMP testing services.
CMC Pharmaceuticals successfully extended operational shelf-life of a medical countermeasure, resulting in new FDA approval.
A recent, unannounced FDA cGMP inspection concluded with no objectionable conditions, supporting the company's cGMP testing capabilities.
CMC Pharma subcontracted for a Nerve Agent Countermeasure Development Program.
Discusses challenges and solutions for accelerating pharmaceutical development cycles for emerging companies.
Celebrated five years since founding in 2014, marking the growth from a consulting firm to a company with R&D and cGMP laboratories and increased staff.
First unannounced FDA cGMP inspection resulted in no objectionable conditions (no Form 483 issued), affirming compliance for cGMP testing services.
CMC Pharmaceuticals successfully extended operational shelf-life of a medical countermeasure, resulting in new FDA approval.
A recent, unannounced FDA cGMP inspection concluded with no objectionable conditions, supporting the company's cGMP testing capabilities.
CMC Pharma subcontracted for a Nerve Agent Countermeasure Development Program.
Discusses challenges and solutions for accelerating pharmaceutical development cycles for emerging companies.