Getting products to market involves more than the science; it requires robust documentation and eventual submissions and filings to Health Authorities. While it’s understandable for organizations to focus on Regulatory Strategy and CMC especially in early stages, it’s important to recognize the role of Regulatory Operations (RegOps) in ensuring that organizations are equipped with the processes and systems/tools to enable an organization to submit documents/applications and accelerate approvals. Menesa Consulting is focused on RegOps services and aims to help organizations define and/or strengthen processes and related systems/tools. How? By quickly getting to know your organization, learning about your goals and making impactful recommendations with meaningful considerations to people, process and technology.

Menesa Consulting can provide various levels of engagement depending on your needs—from high level strategy advising to direct interactions with vendors/teams to interim operational roles, filling in gaps until resources are in place—at the time you need. Whether you’re at the beginning of business process definition, amid RIM implementation, or have recently gone live, Menesa Consulting is ready to help.