Regulatory CMC Support

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

Developing an end-to-end CMC strategy customized to both the stage at which your product is currently under development and the regulatory environment landscape in play.

For preparing the CMC Documentation and a Review of Submission

CMC Documentation; writing and reviewing CMC documentation to comply with agency expectations for fillings IND, NDA or BLA.

Compatibility and Stability

Design and verification of shelf-life specifications, including stable history qualifications, the key stability-indicating variables, and the stability profile of your products.

Over an extended time, more than 50% of these biopharmaceutical executives had interactions with regulatory agencies estate.

Improving stakeholder interactions in regulatory meetings and submissions.

GMP Compliance Support

You need to make sure that your manufacturing processes are compliant with Good Manufacturing Practices (GMP) as per food and drug regulatory requirements.

Post-Approval CMC Management

Ongoing CMC support after approval to deal with changes or upgrades in the manufacturing process.

Realize the CMC Excellence with BioBoston Consulting

Our CMC services give you the best chance of getting your regulatory submissions through and that the product development process is on track for regulatory compliance at every stage. We can facilitate your regulatory road map from preclinical work to clinic.

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.