Regulatory CMC

Regulatory Chemistry, Manufacturing, and Control (Reg CMC) strategy is a vital component of drug development, spanning from the initial concept through to the marketing application and ongoing commercialization. Integrating Reg CMC expertise into your development plans is essential to avoid costly delays and prevent unnecessary or redundant work, which can diminish the overall value of a drug development project.

A well-crafted Reg CMC strategy ensures that the development timeline meets regulatory requirements and standards, while also providing flexibility and optionality where possible. Given our frequent engagements with the US FDA, we are well-positioned to offer guidance on the agency’s current expectations and collaborate with our clients on topics currently under scrutiny by the FDA.

Our goal is to provide comprehensive Reg CMC strategic advising that not only aligns with regulatory expectations but also enhances the efficiency and success of your drug development efforts.