Comprehensive Regulatory CMC Support from Development to Market
Mastering the complexities of Chemistry, Manufacturing, and Controls (CMC) requirements is essential for successful drug development. We offer thorough CMC regulatory support, backed by extensive industry experience (over 150 years in total) and a proven history of success (see testimonial page). Our specialists assist you through every stage of CMC development, from formulating robust CMC strategies to achieving marketing authorization.
We provide customized solutions to suit your unique requirements, whether you need ad-hoc services, help with specific projects, or a completely outsourced team.
What can we do for you?
Our CMC regulatory consultants have extensive experience and expertise to support you through all stages of CMC development and the regulatory approval process.
We specialize in regulatory consultancy support during the development and registration of:
- Small molecules (including generics)
- Biologics (including biosimilars)
- Vaccines
- Advanced therapy medicinal products (ATMPs), including cellular and gene therapy products
Partnering with us can help your regulatory submissions and accelerate your journey from development to market. Our goal is to ensure your products reach patients safely and efficiently.
When required for your project, we can provide a collaborative approach to ensure seamless integration with other disciplines, including non-clinical, clinical, and regulatory. This comprehensive support guarantees that your CMC program is fully aligned with overall development and regulatory strategies.