Chemistry, manufacturing and controls (CMC) is a broad discipline critical to the design, development and manufacture of safe and efficacious pharmaceutical products. Our CMC professionals provide experienced consultation in drug substance manufacture, drug product manufacture, formulation, delivery, analytical test methods development, as well as CMC regulatory expertise. We can assist with your drug development needs from minimally qualified products for Phase 1 clinical studies to fully validated products for Phase 3 clinical trials. Our team of experts will provide strategy for the most efficient development pathway from synthesizing active pharmaceutical ingredient (API) to packaging the finished product. We will work with your project management teams and provide as much or as little assistance as you require.
We assist with combination drug product development and CMC issues during pre-clinical, clinical, and post-marketing development phases, including toxicology, pharmacology, formulations development, and improvement; drug delivery systems design, development, and improvement; formulation and drug delivery system compatibility, formulations, and drug delivery systems manufacturing and process scale-up; and stability of drug delivery combination products, product performance optimization and improvement, and product safety and reliability. We also have expertise in the design, development, performance evaluation, and optimization of drug delivery systems such as propellant metered dose inhalers (pMDIs), dry powder inhalers (DPIs), and nebulizers; powder design and coating technologies; controlled-release polymers and hydrogels; oral, transdermal, and buccal deliveries.
We can assist our clients in manufacturing-process analysis and improvement; trouble-shooting and process FMEA; as well as process verification, validation, and statistical process control. We have extensive experience in handling root-cause analysis to identify issues leading to manufacturing inconsistencies and to products failing to pass quality control metrics.
We have expertise in supporting regulatory strategy development for pharmaceutical drug product registrations in the U.S. and internationally by working alongside our clients’ regulatory teams. Exponent scientists have successful experience with the regulatory agency interactions necessary for product submissions, clinical and technical development plans, and post-marketing issues. We also assist our clients in quality systems implementation and improvement for compliance with Good Laboratory Practices, Good Manufacturing Practices, and ISO 9000, as well as manufacturing procedures analysis.
CMC Drug Substance and Drug Product Services
- Small molecule and biologics development and manufacture strategy
- CMO selection and management
- CRO management of packaging, labeling and distribution of clinical trial material
- Preparation of CMC sections for regulatory submissions (IND/NDA, CTA/MAA, BLA, ANDA etc)
- Drug Master File (DMF) assembly
- Preparation of other regulatory submissions (i.e., annual reports, amendments, and supplements)
- Preparation of other regulatory submissions (i.e., annual reports, amendments, and supplements)
- Development of protocols for various drugs dosage forms (i.e,. aerosol, capsules, transdermal and parentreal) including comparability, performance, optimization, preservative effectiveness, biocompatibility, microbiology, extractables and leachables, stability, and sterility effectiveness
- Powder characterization including particle size distribution, spray pattern, and plume geometry
- Excipient selection
- Drug delivery systems, primary and secondary packaging design, and development and optimization