CMC
We offer comprehensive end-to-end process support for your CMC efforts–from early development and optimization endeavors, to progressing through scale-up during advanced development, to supporting your end commercial process. Consider us your trusted CMC partner throughout the entire process. Our consultants each have an average of more than 20 years of experience in the Pharma industry, from Development, Operations, Technical Services, Quality Assurance, Quality Control, Compliance, and Auditing. We provide expertise in formulation and design, process optimization, scale-up, technical transfer, CDMO selection/management, technical design, fill/finish, and protocol review, and our experience spans API, Drug Substance, and Drug Product activities.
Our team seamlessly integrates our resources with your team, so you can address technical hurdles or compliance obligations without undermining normal operations. We support the authoring of various key documents, including policies and procedures, validation master plans, technical protocols, oversight of sampling and testing programs, authoring final technical and stability reports, and providing Quality Systems expertise oversight, among other tasks.
Our CMC Consulting Services include:
- Manufacturing API/DS/DP
- Clinical
- Commercial
- CDMO selection and oversight
- Supplier selection
- Supply Chain
- Technical Support and Oversight
- Process Design and Development
- Sourcing – Raw/API/Filling
- Scale-Up
- Tech transfer
- CDMO selection
- Process Validation
- Laboratory System Controls
- Data Analysis
- Stability
- Specifications
- Analytical Methods
- Laboratory Deviations OOS/OOT
- Instrument Qualification
- Laboratory GMP Oversight
- Quality Assurance and Compliance
- Quality Systems and Compliance Oversight
- Master Records/Record Review
- Disposition
- Change Management
- Supplier Audits
- Regulatory Inspections
- Deviations Management CSV
For more information about how we can support your CMC efforts, please contact Georgia Sloboda.
