Regulatory CMC Support
Making Compliance Easier and Development Faster
Alignment of Chemistry, Manufacturing, and Controls (CMC) with regulatory expectations is essential to successfully develop new therapies in a highly-regulated industry such as life sciences. BioBoston Consulting offers customized Regulatory CMC services supporting the development of your product from preclinical through clinical stages to comply with all regulatory requirements.
Why BioBoston Consulting for Regulatory CMC Support?
Expert CMC Guidance
Our team has extensive hands-on experience managing the complex CMC regulatory demands on life sciences companies. Whether you need help with drug substance and product specifications, or stability data, BioBoston Consulting experts can keep your development program moving forward.
Preclinical and clinical knowledge.
From the earliest preclinical studies to later-stage clinical trials, our CMC partners provide full support throughout development that helps you meet regulatory requirements, minimize your risk and shorten timelines.
Regulatory Insight
Our team keeps current on regulatory standards so your CMC submissions always conform to the latest expectations. We deliver practical solutions for handling the engineering aspects of product development, and we support regulatory interactions to obtain approvals.
Global Compliance
We provide international CMC regulatory assistance in support of compliance with global regulatory needs by the FDA, EMA and other regional global bodies.
Regulatory CMC Services Include
- CMC Strategy Development
- For preparing the CMC Documentation and a Review of Submission
- Compatibility and Stability
- GMP Compliance Support
- Post-Approval CMC Management
- Realize the CMC Excellence with BioBoston Consulting
Contact Us Today
Contact us and discover what BioBoston Consulting can offer to you for your CMC requirements in development of product throughout the lifecycle.
All Services
- Quality Assurance and Regulatory Compliance
- Investigational New Drug (IND) Application
- Regulatory Strategy & Submissions
- Investigational Device Exemption (IDE) Application
- Vendor Selection & Qualification
- Project & Risk Management
- Technology Transfer
- Quality Management Systems (QMS)
- Gap Assessment and Remediation
- Funding and Investment Strategies
- Research and Development (R&D)
- Biostatistics and Data Analysis
- Lab Operations and Efficiency
- Medical Writing
- CDMO Vendor Selection Qualification & Oversight
- CRO Selection & Qualification
- CTO Selection & Qualification
- Data Integrity and Software Implementation
- Clinical Operations
- Clinical Trial Monitoring
- FDA Inspection Readiness
- Internal and Supplier Audits
- Regulatory CMC Support
- Qualification and Validation
- GxP Training
- Computer System Validation (CSV)
- Strategic Advising
- Process Optimization
- Health Authority Meeting Support
- Recruitment