Services
How We Help
With a proven track record across multiple disciplines, we bring expertise in general management, scientific leadership, process validation, commercialization, project management, and regulatory strategy. We have successfully guided drug substance development from early-phase research to product launch, ensuring alignment with both business goals and regulatory requirements. By bridging technical expertise with operational efficiency, we drive projects forward, mitigate risks, and optimize processes. Whether leading teams, overseeing operations, or ensuring compliance, we deliver strategic, results-driven solutions to complex challenges.
Chemical process evaluation
It is important to routinely evaluate if a manufacturing processes will be able to reliably deliver within rigorous quality and regulatory standards. We can help evaluate current chemical syntheses for phase appropriate robustness, scalability and regulatory compliance.
Vendor selection and project management
Selecting the right CDMO to develop and manufacture a drug is one of the most important decisions in the project lifecycle. With over 25 years working in the CDMO space we can both, expertly assess which CDMO’s are the best fit for your project, as well as manage placed projects on your behalf to ensure the best outcomes.
Drug substance CMC strategy
Developing compliant manufacturing, material control, specifications and impurity control strategies will evolve over the development life cycle. We can assist in what aspects of your manufacturing process to develop, and when, to reduce timelines and future regulatory risks.
Technical writing
Chemistry, Manufacturing and Controls (CMC) is a critical component of regulatory submissions (Ex: IND, NDA, ANDA). We can assist in writing a sound submission that is precise and concise, with solid justifications of the strategic choices made during the development phase of your project.
