cmc regulatory

Pre-IND Meetings, Preparation and Review of Regulatory Submissions

PRE-IND MEETING requests; Pre-ind briefing books

Before initiating a clinical trial—and again after completing a study or preparing for the next phase—companies often encounter scientific and regulatory questions that benefit from early engagement with Health Authorities. These interactions help ensure that CMC strategies, data packages, and development assumptions remain aligned with current regulatory expectations and support a smooth progression through the clinical development pathway.

In collaboration with our colleagues at Kinexum Services LLC, we help clients frame questions clearly, develop scientifically sound justifications, and prepare well‑structured CMC packages for Pre‑IND meetings—ensuring productive, informed interactions with regulatory agencies.

With so many potential CMC questions to raise with a Regulatory Agency, CMC‑Rx Consultancy helps you determine which aspects of your development program truly warrant discussion during FDA meetings. We review your existing CMC documentation, engage directly with your development team, and identify the scientific and regulatory issues that would benefit from early agency feedback.

We then formulate clear, well‑structured questions for submission to Health Authorities and prepare the corresponding CMC sections of your Pre‑IND briefing package—ensuring that your meeting materials are coherent, scientifically justified, and aligned with your overall development strategy.

review of ind, IMPD & CTA submissionS

Ready to file an IND, IMPD, CTA, but would like an external consultancy agency to review your CTD submission? CMC-Rx Consultancy reviews Module 3, CMC Chapters 3.2.S and 3.2.P.

authoring of CMC sections of inD, IMPD and CTA

With deep expertise in chemistry and CMC strategy, CMC‑Rx Consultancy also authors comprehensive CMC sections (CTD Modules 3.2.S and 3.2.P) for IND, IMPD, and CTA submissions.

When we have been directly managing the drug substance and drug product development programs, it is a natural extension of our work to prepare the corresponding CTD sections—ensuring that all CMC information is accurate, coherent, and fully aligned with the development history and regulatory expectations.