CMC Advisory Regulatory Services
DDReg’s CMC services help organizations develop robust product strategies that support the creation of sound, high-quality CMC documents across all phases of development—from authoring and reviewing to submission. Backed by over a decade of experience, our team leverages strategic data generation to ensure globally compliant, high-quality regulatory filings.
DISCOVER MOREOur Comprehensive CMC Regulatory Approach
Our seasoned team of CMC regulatory affairs consultants develops a tailored CMC Regulatory Strategy designed to align with the evolving expectations of regulatory agencies around the globe. We integrate Quality by Design (QbD) principles and proactive risk assessments to build a strong foundation for every phase of your product lifecycle. This structured approach enables us to identify potential compliance challenges early and address them before they affect your regulatory submissions.
By maintaining a rigorous review process, our experts meticulously assess every detail of your technical documentation. We ensure that all manufacturing processes, controls, and quality standards meet or exceed regulatory requirements. This systematic review optimizes your filing efficiency but also reinforces your overall CMC Regulatory Strategy for sustained success in the global marketplace.
Expert CMC Advisory for quality regulatory filings
At DDReg provide end-to-end support in CMC Regulatory Affairs with comprehensive reviews of technical documentation, detailed risk assessments, and the preparation of CMC assessments reports for regulatory submissions such as IND applications, NDAs, and MAAs. Our Regulatory Review process incorporates essential aspects like injectable packaging, extractable & leachable testing, sterilization techniques, and API selection. With a commitment to excellence, our experts work diligently to ensure that every document is aligned with international regulatory expectations.
Our holistic methodology leverages innovative tools like our QbD Planning Tool, which helps embed quality into every stage of product design and development. Through ongoing monitoring and end-to-end CMC regulatory services, we empower our clients to adapt swiftly to regulatory changes. Our proactive approach ensures that your CMC Regulatory Strategy remains robust and current, ultimately reducing time-to-market and ensuring consistent compliance.
Our CMC Advisory Expertise
- Quality by Design (QbD) Planning and Implementation
- Injectable Packaging – Extractable & Leachable Testing, Sterilization Techniques
- Drug Device Combination Products Strategy
- API Selection Based on Key Starting Materials (KSM)
- Exhibit Batch Preparation and Detailed Review
- Comprehensive Review of CMC Documentation Regulatory Affairs
- Preparation & Review of CMC Sections (Modules 1, 2 & 3)
- Ongoing CMC Regulatory Intelligence and Compliance Monitoring
Ready to streamline your regulatory submissions and achieve faster market access?