IDE/IVD Solutions

Delivering What is Required for IDE and in-vitro Diagnostic Submission Success

MolecularMD has established the organizational framework required to bring a prototype clinical trial assay along the codevelopment continuum into a companion diagnostic. This core competency that MMD possesses is the result of over a decade of experience with multiple clients. At the center of this capability are the facilities and skilled intellectual capital that work together as a cohesive team.

IDE/IVD Solutions

Delivering What is Required for IDE and in-vitro Diagnostic Submission Success

MolecularMD has established the organizational framework required to bring a prototype clinical trial assay along the codevelopment continuum into a companion diagnostic. This core competency that MMD possesses is the result of over a decade of experience with multiple clients. At the center of this capability are the facilities and skilled intellectual capital that work together as a cohesive team.

Program Management

For every client’s drug program, a project management team is assembled from the relevant functional areas and is dependent on the scope and requirements of…

CAP/CLIA Certified Laboratories

MMD’s two CAP-accredited / CLIA-certified laboratory sites track patient samples, providing chain of custody from accessioning, extraction, testing, data…

cGMP Manufacturing

There are instances when clients want to run a MMD-developed assay at an external site. In such cases, MMD utilizes its cGMP manufacturing kitting capabilities…

Regulatory Department

MMD’s experienced regulatory team routinely submits data and filings to the FDA and ex-US regulatory agencies on behalf of their clients: Study Risk…

Data Management and Quality Management System

The backbone of MMD’s IDE/IVD Solutions is our information technology (IT) infrastructure which is fully documented for easy access and review by our…