Ensure Your Pharmaceutical Products are Effectively Manufactured for the Full Lifecycle

Getting Chemistry, Manufacturing, and Controls (CMC) right from the start can make or break your product development timeline and budget. That’s why we tackle CMC considerations early, with a strategic approach that reduces risk, avoids costly delays, and sets you up for long-term success.

We combine deep CMC, regulatory, and clinical expertise to tailor solutions to the unique and complex needs of each program. Whether you need targeted support or full-service management of development, manufacturing, and testing, we partner with you to navigate each milestone—right through to the successful submission of your regulatory dossier.

End-to-End Expertise

Our team has significant experience supporting and managing product development programs for a wide variety of small molecules and biologics. We’ve helped sponsors overcome complex CMC challenges to successfully complete product development programs and CMC dossiers for Investigational New Drugs (INDs), Clinical Trial Applications (CTAs), Biologics License Applications (BLAs), and New Drug Applications (NDAs).

What We Deliver:

• Strategic CMC Planning: We’ll help align your development goals with regulatory expectations from day one.
• Formulation and Process Design: We bring scientific insight to over strategic input on formulation and manufacturing process design.
• Analytical Method Development: We guide and support phase appropriate development and qualification or validation of discriminating analytical methods.
• Protocol and Documentation Support: We prepare and review critical CMC documentation, including technical protocols and reports, to ensure submission readiness.
• Global Regulatory Readiness: We’ll define optimal validation strategies to ensure compliance with guidelines from FDA, ICH, and other global regulatory bodies.

A Network That Works for You

With a robust network of contract development and manufacturing organizations (CDMOs), we help you identify the most suitable service providers for your drug substance and drug product, ensuring optimal performance and regulatory compliance—within your desired timeline or budget.

Our Comprehensive CMC Capabilities:

• Drug Product Development: From API and excipient sourcing to Quality by Design (QbD) analytical, formulation, and process development, plus technical document preparation and review
• Clinical Trial Material: Phase-appropriate manufacturing, packaging and labeling planning and oversight, and maintenance support for clinical material quality attributes
• Scale-Up and Manufacturing Strategy: Strategic oversight of vendor and facility selection, manufacturing process development, and optimization and validation of process technology transfers
• Regulatory CMC Documentation: Technical and regulatory document preparation, review, and adjudication at every stage of development

Let’s Move Your Program Forward—With Confidence

Wherever you are in development, we’re ready to help. Contact Premier today to meet with our experts and discuss the best CMC strategy for your development program.